POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
This recall is currently active, issued April 12, 2024. It was issued by Surgical Specialties.
- Company
- Surgical Specialties
- Recall Initiated
- March 26, 2024
- Posted
- April 12, 2024
- Recall Number
- Z-1534-2024
- Quantity
- 2,459 units
- Firm Location
- Westwood, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints have been received with allegations of Incorrect Needle Curvature.
Distribution
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Lot / Code Info
Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;
Root Cause
Process control
Action Taken
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 will replace the product at no charge. If you have any questions, contact complaints@corza.com.