Device recall
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8384P (HSI Item No. 600-7664); Product Description: Sterile, synthetic, nonabsorbable, monofilament 6-0 blue polypropylene surgical suture, 18-inch length, with C-17 3/8-circle surgical needle. Component: N/A;
- Recall number
- Z-0342-2027
- 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
- 137
- Code info
- Model/Catalog Number: PSN8384P (HSI Item No. 600-7664); UDI-DI: 10889950001865; Lot Numbers: 0624002HF, 0625001HF, 0625002HF, 0625003HF, 0625017HF, 0625022HF, 0625027HF;
- Distribution
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
- Location
- Denver, PA