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PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 ...

FDA Device Recall #Z-2486-2020 — Class II — June 10, 2020

Recall Summary

Recall Number Z-2486-2020
Classification Class II — Moderate risk
Date Initiated June 10, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ethicon, Inc.
Location Somerville, NJ
Product Type Devices
Quantity 99,612 eaches

Product Description

PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870

Reason for Recall

Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years

Distribution Pattern

No domestic distribution. Foreign distribution to Algeria Angola Australia Austria Azerbaijan Bahrain Belgium Bosnia and Herzegovina Canada Chad Chile Czechia Egypt Finland France Gabon Germany Greece Hong Kong Iceland India Iran Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Lebanon Libya Lithuania Mauritius Morocco Mozambique Netherlands (the) New Caledonia New Zealand Nigeria Oman Philippines Poland Portugal Qatar Republic of North Macedonia Russian Federation (the) Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates (the) United Kingdom of Great Britain and Northern Ireland (the)

Lot / Code Information

Lots JPM942 KL6991 LGM827 LEZ809 MK6383 MMZ678 JLK294 KDZ665 KGK318 LB6583 LBZ323 MHZ265 JKM117 KGZ428 LCM926 LJ6781 JK5467 KG6391 KGK122 LDM751 LGM998 MLZ444 JJH828 JJQ472 JPE958 JPH660 JPJ413 KDB811 KDP880 KEA813 KED040 KEH484 KJH714 KKH186 KKH414 KKH422 KKJ413 KKQ351 LAH173 LAH250 MLQ803 MLQ983 LMH564 MLH118 JHH622 JKH290 JKH291 JKJ367 JMH262 JMH451 KCJ065 KCJ468 KGH971 KGJ788 KJH581 KKJ280 KMH239 LBJ014 LEH309 LMB752 MCQ954 MEB754 MKH209 KHJ240 LMH575 MCH323 JPE551 JPH615 JPJ120 KAH393 KDB810 KDH640 KDH719 KDP776 KED059 KEE862 KEH320 KEH438 KEH483 KJH266 KJH284 KJH948 KJJ285 KJJ336 KJJ971 KKP008 KKQ042 KKQ106 MEQ614 MJH320 MLA210 MMH143 KCB768 KDE561 KDE646 KDH112 KDH113 KDH114 KDH204 KDH205 KDH330 KDH361 KDH362 KGJ025 LBH039 MAB866 MGQ557 MHB435 MHB476 MHH396 MJH936 MKH098 MKH779 MLH064 JLJ429 JLJ813 JLQ137 JMJ111 JMJ541 JPH389 JPH467 JPH614 JPJ048 JPJ119 JPJ353 JPP592 JPP795 KJQ327 KKP006 KLH997 KPR661 LCJ238 LPB629 LPH954 MHB548 MKH419 MKH511 MKH533 MKQ474 MLH817 MLJ838 MMB871 MMH381 MEQ276 MJQ277 MMH382 MPJ283 JJP588 KGJ148 LCJ335 MCH324 MEJ543

Other Recalls from Ethicon, Inc.

Recall # Classification Product Date
Z-0487-2025 Class II MONOCRYL" (poliglecaprone 25) Suture REF Y936H ... Oct 8, 2024
Z-0319-2025 Class II Coated VICRYL Polyglactin 910 Suture VIO 36IN(9... Sep 25, 2024
Z-2148-2024 Class II MONOCRYL (poliglecaprone 25) Suture - Intended ... May 10, 2024
Z-2144-2024 Class II VICRYL (polyglactin 910) Suture - Indicated for... May 10, 2024
Z-2147-2024 Class II PDS Plus Antibacterial (polydioxanone) Suture -... May 10, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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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