PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05...
FDA Recall #Z-2617-2023 — Class II — August 10, 2023
Product Description
PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z421H-50, Z421H-50, Z421H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z423H-50, Z423H-50, Z423H-50, Z442H-50, Z442H-50, Z442H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z489G-50, Z489G-50, Z489G-50, Z489G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z494G-50, Z495G-05, Z495G-05, Z495G-05, Z496G-50, Z496G-50, Z496G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z503G-50, Z504G-50, Z507G-50, Z507G-50, Z683G-05, Z833G-05, Z833G-05, Z844G-50
Reason for Recall
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Recalling Firm
ETHICON, LLC — Guaynabo, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
868,363 total units
Distribution
US Nationwide. Global Distribution.
Code Information
UDI-DI: 10705031026742, 10705031031234, 10705031032620, 10705031033894, 10705031134386, 10705031134492, 10705031118102, 10705031073487, 10705031149410, 10705031149427, 10705031075443, 10705031149441, 10705031149472, 10705031086906, 10705031130296, 10705031130302, 10705031082960, 10705031151819, 10705031130333, 10705031130357, 10705031130357, 10705031130418, 10705031130418, 10705031083028, 10705031130425, 10705031130562, 10705031151895, 10705031151895, 10705031151901, 10705031151918, 10705031130708, 10705031130722, 10705031131057, 10705031131057, 10705031461536, 10705031060340, 10705031113602, 10705031113619, 10705031060852, 10705031114050, 10705031060876, 10705031060883, 10705031114067, 10705031060890, 10705031060906, 10705031114074, 10705031114081, 10705031060913, 10705031114111, 10705031060968, 10705031060975, 10705031060982, 10705031114135, 10705031060999, 10705031061002, 10705031114142, 10705031114258, 10705031061132, 10705031061149, 10705031114265, 10705031114272, 10705031061156, 10705031061163, 10705031114296, 10705031061170, 10705031061187, 10705031061194, 10705031114319, 10705031061217, 10705031061224, 10705031114333, 10705031061231, 10705031467217, 10705031061248, 10705031114340, 10705031061255, 10705031061262, 10705031061279, 10705031061293, 10705031061309, 10705031061323, 10705031061347, 10705031061385, 10705031061460, 10705031061507, 10705031061538, 10705031061545, 10705031114654, 10705031061828, 10705031061835, 10705031061842, 10705031467354; Lot Numbers: RGMBEK, QMMCKS, QLMKHK, REMMRB, RKMASZ, PBM649, SJMLRE, PG6842, QJMCQC, QLMBXL, QKMKRK, QLMDJA, QLMJQH, QMMAKJ, QMMLBP, QPMCMQ, RCMJDB, RCMPXB, RDMERH, RGMDMM, RGMDBJ, SCMJET, REMJAJ, MKZ221, QPMDDQ, QPMDHD, RBMAJE, RGMAQU, RHMBMR, RLMPMM, QGMHTJ, QKMMPQ, RCMKHS, MMK957, QMMCPS, RDMKAJ, REMKDP, QHMMPR, RKMAAS, SGMCTP, REMBUE, RKMMTD, SCMAXS, QHMEDK, REMEQC, RJMPQP, QKMHTR, QLMKPU, QMMHUU, RAMLZJ, RDMACU, RDMECL, RGMLCS, SCMELT, QBMBQA, QBMKCR, RPMBJS, SBMJZM, QLMDDC, QLMPAR, QPMBDT, RGMBBK, RHMJHU, QHMMEP, QLMDDQ, QMMBQJ, RCMRUD, RGMALA, RCMBDB, TBMDPK, PGZ426, QKMHTM, QKMHRP, QLMHBX, QPMBMD, QPMDBX, RCMJEK, RDMDAS, RKMDJA, RLMHPQ, QPMCAD, RGMDBP, QCMCZZ, RJMLEL, TAMQSS, MPZ365, SCMBJZ, RBMEDE
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated