CLASS II ONGOING Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
Perma-hand/Mersilk Silk Blu and Virgin Silk Blu recalled by Ethicon
Ethicon is recalling Perma-hand/Mersilk Silk Blu and Virgin Silk Blu, Product Codes EH7457G EH7983G FV768. The recall was initiated on 10 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2486-2020
- FDA event ID
- 85820
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2020
- FDA classified
- 2 Jul 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2020 | Recall initiated by company | |
| 2 Jul 2020 | Classified by FDA | +22 days |
| 8 Jul 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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)
Questions about this recall
Is Perma-hand/Mersilk Silk Blu and Virgin Silk Blu, Product Codes EH7457G EH7983G FV768 recalled?
Yes. Ethicon recalled Perma-hand/Mersilk Silk Blu and Virgin Silk Blu, Product Codes EH7457G EH7983G FV768 on 10 Jun 2020. The recall is Class II and its status is Ongoing. Recall number Z-2486-2020.
Why was it recalled?
Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
Which lots are affected?
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
Where was it sold?
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)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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