Recall Z-0116-2021 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
| Date | Sep 9, 2020 |
| Status | Terminated |
| Reason | Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles |
| Root cause | Packaging process control |
| Action | Ethicon issued Urgent Medical Device Recall Removal letter on 9/09/20 via email to responsible Johnson & Johnson Affiliates in affected countries who will be contacting all their impacted primary and secondary consignees and/or end customers. The letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall onhand and quarantine such product(s). 2.Remove the product subject to this recall and communicate the issue to relevant operating roomor materials management personnel, or anyone else in your f |
| Quantity | 1,032 eaches (OUS only) |
| Distribution | International distribution including the countries of Australia, Canada, Japan, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.