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U.S. Department of Health and Human Services

Class 2 Device Recall MERSILK and PERMAHAND, Braided Silk and Virgin Silk NonAbsorbable Suture

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 Class 2 Device Recall MERSILK and PERMAHAND, Braided Silk and Virgin Silk NonAbsorbable Suturesee related information
Date Initiated by FirmJune 10, 2020
Create DateJuly 02, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2486-2020
Recall Event ID 85820
510(K)NumberK946173 
Product Classification Suture, nonabsorbable, silk - Product Code GAP
ProductPERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
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 
FEI Number 2210968
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information ContactEthicon Customer Support Center
877-384-4266
Manufacturer Reason
for Recall		Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThere is no US impact. The firm began notification of customers on June 10, 2020 via URGENT FIELD SAFETY NOTIFICATION letters. Customers were informed that the shelf life of the product is being reduced from 5 years to 3 years (36 months). Any 8-0 Blue Twisted Silk Suture product received prior to June 2019 labeled with an expiration date of 2024-06-20 or earlier is affected by this Field Safety Notification. Customers were asked to acknowledge the notification by completing and returning the business reply form included with the mailing. If you have additional questions regarding this Field Safety Notification or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET. ***Updated 6/29/20*** On 6/12/2020, the recalling firm updated the field action from "Notification" to "Removal". All affected devices are now required to be returned.
Quantity in Commerce99,612 eaches
DistributionNo 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)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GAP
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