Device recall
Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN683S (HSI Item No. 600-6411); Product Description: Sterile, natural, nonabsorbable, braided 4-0 black silk surgical suture, 18-inch length, with C-6 18.7 mm, 3/8-circle reverse-cutting needle. Component: N/A;
- Recall number
- Z-0339-2027
- 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
- 140
- Code info
- Model/Catalog Number: PSN683S (HSI Item No. 600-6411); UDI-DI: 10889950001605; Lot Numbers: 0124001HF, 0124002HF, 0125009HF, 0125010HF, 0125026HF, 0125034HF, 0125040HF, 0125041HF
- Distribution
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
- Location
- Denver, PA