Device recall
Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN632S (HSI Item No. 600-3506); Product Description: Sterile, natural, nonabsorbable, braided 3-0 black silk surgical suture, 18-inch length, with C-9 1/2-circle surgical needle. Component: N/A;
- Recall number
- Z-0337-2027
- Event id
- 100016
- Status
- Open, Classified
- FDA classification
- Class II
- Recalling firm
- Henry Schein Inc.
- Posted
- Nov 3, 2026
- Initiated
- Sep 17, 2026
- Product code
- GAP
- Device type
- Suture, Nonabsorbable, Silk
- Reason
- Products lack 510(k) clearance.
- Root cause
- Process control
- Quantity
- 20
- Code info
- Model/Catalog Number: PSN632S (HSI Item No. 600-3506); UDI-DI: 10889950001506; Lot Numbers: 0125008HF, 0125016HF, 0125028HF, 0125031HF;
- Distribution
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
- Location
- Denver, PA