Recall Z-0335-2027 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Henry Schein Inc.
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;
| Date | Nov 3, 2026 (initiated Sep 17, 2026) |
| Status | Open, Classified |
| Reason | Products lack 510(k) clearance. |
| Root cause | Process control |
| Action | On September 25, 2026, URGENT: MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. ACTION: Please examine your inventory to determine whether you have affected product. If affected product is identified, immediately cease distribution and use, remove the product from available inventory, and follow the return instructions provided. The product must be returned within 30 days to Henry Schein s Returns Facility located at: 41 Weaver Rd, Denver, PA 17517. |
| Quantity | 21 |
| Distribution | Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.