Device recall
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8698P (HSI Item No. 600-5659); Product Description: Sterile, synthetic, nonabsorbable, monofilament 5-0 blue polypropylene surgical suture, 18-inch length, with C-3 premium reverse-cutting needle. Component: N/A;
- Recall number
- Z-0338-2027
- 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
- GAW
- Device type
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Reason
- Products lack 510(k) clearance.
- Root cause
- Process control
- Quantity
- 33
- Code info
- Model/Catalog Number: PSN8698P (HSI Item No. 600-5659); UDI-DI: 10889950001957; Lot Number: 0624014HF;
- Distribution
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
- Location
- Denver, PA