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Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2)...

FDA Device Recall #Z-0916-2025 — Class II — November 8, 2024

Recall Summary

Recall Number Z-0916-2025
Classification Class II — Moderate risk
Date Initiated November 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 512,786 total units

Product Description

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE , Catalog Number: POHFSPMH1; 62) KIT, SPINE , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS

Reason for Recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Lot / Code Information

Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J34J41 ; Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J43U77 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952G ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J53W73 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952H ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J6050F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J74A27 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7963D ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7905F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J84K02 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J8692Y ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J86T82 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 20166041-3014 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 5138318 ; Catalog Number PN33MSOC3, UDI/DI 10197106660881 (EA)50197106660889 (CS), Lot Number 7331471 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7265882 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7280085 ; Catalog Number PN33MSOCI, UDI/DI 10197106586525 (EA)50197106586523 (CS), Lot Number 7265980 ; Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number J9601U ; Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number J96A01 ; Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number J9601W ; Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number 5138235 ; Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number J70X03 ; Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number 5664035 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J30T23 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4951J ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J53W36 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J7704A ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4678M ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4949U ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J6049W ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J79F27 ; Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number J7704A ; Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number J6786F ; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number BCS725327015001; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number 5138322 ; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number 5530911 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332852 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6748343 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6701994 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6563921 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6806107 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6487885 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7265878 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7287503 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280085 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7331468 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7331303 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332852 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7102720 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6264449 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6986975 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7005435 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6907766 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7122068 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7284052 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280047 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280048 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7287482 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280050 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332804 ; Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number 5618930 ; Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number 5891287 ; Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number 6487884 ; Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number 6485582 ; Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number 6748342 ; Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number 6264449 ; Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number 6806107 ; Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number 6701970 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7110268 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7265878 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7122068 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7287457 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7360338 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7332852 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701996 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6775018 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6806107 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265879 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280085 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7331306 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7349669 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701995 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701994 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7045815 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280047 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701942 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7058621 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7005446 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7286183 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280044 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280044 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280059 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280048 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7331284 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7332832 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701957 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6568661 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6563990 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6487901 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6914944 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928766 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928764 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7127056 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7160537 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928773 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7163104 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7280110 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7280109 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928772 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7332910 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 2407826964 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928770 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6345524 ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4951J ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4949R ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4877G ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J79H44 ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J7904N ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J8064U ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number 5775791 ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number J6049X ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number 5664045 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number 6279851 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number 6264450 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number 6345509 ; Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number 6345507 ; Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number 6485580 ; Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number 6364783 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J7498G ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J84J96 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J7704A ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J7609N ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J76N06 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J89H91 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J89C53 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J6785Z ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J70X09 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J8670W ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J86Y70 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J9601U ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J68T47 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J86N64 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J6910U ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J70X08 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J96N37 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J9699Z ; Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number 5631051 ; Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number 5631025 ; Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number 5533325 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number H2357570 ; 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Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number J37U15 ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J4951H ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J53W05 ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J4877M ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J4952U ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J5677Z ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number N/A ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J6049T ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J6278J ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J43U79 ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J5678C ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J76N04 ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J7904X ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J76D61 ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J79H47 ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J82K98 ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J8064U ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J7963X ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number J84J96 ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number 5136036 ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number 5136012 ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number J9850D ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number J6278F ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number 5311244 ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number 5138330 ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number 5140378 ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J8393F ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J8670J ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J86N65 ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J85W31 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J84J96 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J8670Z ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J6910P ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J70X09 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J9424H ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J6368Z ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J96N36 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J9424M ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J6368U ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number J9601W ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5405610 ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5508050 ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5508060 ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5533338 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5775794 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6487884 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5664021 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5891301 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5970335 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6563795 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6416684 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6487906 ; Catalog Number POHFSPMH1, UDI/DI 10888439747515 (EA)

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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