PlainRecalls
FDA Devices Moderate Class II Ongoing

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

Reported: April 24, 2024 Initiated: March 26, 2024 #Z-1534-2024

Product Description

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

Reason for Recall

Complaints have been received with allegations of Incorrect Needle Curvature.

Details

Recalling Firm
SURGICAL SPECIALTIES
Units Affected
2,459 units
Distribution
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Location
Westwood, MA

Frequently Asked Questions

What product was recalled?
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N. Recalled by SURGICAL SPECIALTIES. Units affected: 2,459 units.
Why was this product recalled?
Complaints have been received with allegations of Incorrect Needle Curvature.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1534-2024.