POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
FDA device recall Z-1534-2024 · posted 2024-04-12 · Open, Classified
Recall details
- Recalling firm
- SURGICAL SPECIALTIES
- Reason for recall
- Complaints have been received with allegations of Incorrect Needle Curvature.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GAM
- Quantity affected
- 2,459 units
- Distribution
- Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
- Date initiated
- 2024-03-26
- Date posted
- 2024-04-12
- Location
- Westwood, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. (K965162) | Lukens Medical Corp. | 1997-02-12 |