POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
FDA Recall Z-1534-2024 · Posted 2024-04-12
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Recalling FirmSURGICAL SPECIALTIES
Recall StatusOpen, Classified
Product CodeGAM
Date Initiated2024-03-26
Product Quantity2,459 units
Reason for Recall
Complaints have been received with allegations of Incorrect Needle Curvature.
Firm 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 will replace the product at no charge. If you have any questions, contact [email protected].
Root Cause
Process control
Distribution Pattern
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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