Recall Z-2617-2023 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
ETHICON, LLC
PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z421H-50, Z421H-50, Z421H-50, Z422H-50, Z422H-50, Z
| Date | Sep 30, 2024 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| Reason | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 8/10/23 was sent to customers. 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 |
| Quantity | 868,363 total units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.