Recall Z-0319-2025 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
| Date | Nov 7, 2024 (initiated Sep 25, 2024) |
| Status | Open, Classified |
| Reason | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: FIELD SAFETY NOTICE was sent to customers beginning on 9/25/24. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contac |
| Quantity | 31,032 units |
| Distribution | International distribution to the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable S ETHICON, Inc., Jun 27, 2019 |