Recall Z-1513-2025 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon Endo Surgery, LLC
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
| Date | Apr 3, 2025 (initiated Mar 7, 2025) |
| Status | Open, Classified |
| Reason | Identified curing issues with the silicone during the needles manufacturing process. |
| Root cause | Process control |
| Action | On March 7, 2025, "URGENT: MEDICAL DEVICE RECALL (REMOVAL)"letters dated March 7, 2025, were 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. 3. Complete the Business Reply Form (BRF) (Atta |
| Quantity | 792 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay. |
| 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 |