Recall Z-2486-2020 ยท GAP Suture, Nonabsorbable, Silk
Ethicon, Inc.
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
| Date | Jun 10, 2020 |
| Status | Open, Classified |
| Reason | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years |
| Root cause | Nonconforming Material/Component |
| Action | There 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 Fiel |
| Quantity | 99,612 eaches |
| Distribution | 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 Li |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK ETHICON, Inc., Jan 9, 1995 |