Recall Z-1534-2024 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
SURGICAL SPECIALTIES
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
| Date | Apr 12, 2024 (initiated Mar 26, 2024) |
| Status | Open, Classified |
| Reason | Complaints have been received with allegations of Incorrect Needle Curvature. |
| Root cause | Process control |
| Action | On March 26, 2024 customers were sent URGENT MEDICAL DEVICE RECALL letters via email. The letters instructed customers to immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of the product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter and the acknowledgement form for product return. We kindly request the return of any affected product that may still be in your stock inventory, and we w |
| Quantity | 2,459 units |
| Distribution | Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. Lukens Medical Corp., Feb 12, 1997 |