Device recall
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN397V (Henry Schein Item No. 600-0331); Product Description: Sterile, synthetic, absorbable, braided 5-0 undyed PGA surgical suture, 27-inch length, with C-6 3/8-circle needle. Component: N/A;
- Recall number
- Z-0335-2027
- 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
- 21
- Code info
- Model/Catalog Number: PSN397V (Henry Schein Item No. 600-0331); UDI-DI: 10889950001308; Lot Number: 0925013HF;
- Distribution
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
- Location
- Denver, PA