Device recall
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN388V (HSI Item No. 600-8803); Product Description: Sterile, synthetic, absorbable, braided 5-0 violet polyglycolic acid (PGA) surgical suture, 18-inch length, with C-22 16.2 mm, 3/8-circle reverse-cutting needle. Component: N/A;
- Recall number
- Z-0343-2027
- 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
- GAM
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Reason
- Products lack 510(k) clearance.
- Root cause
- Process control
- Quantity
- 27
- Code info
- Model/Catalog Number: PSN388V (HSI Item No. 600-8803); UDI-DI: 10889950001261; Lot Numbers: 0924004HF, 0925023HF;
- Distribution
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
- Location
- Denver, PA