Class II

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

SURGICAL SPECIALTIES · March 26, 2024

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.

States Affected

AZ, CA, IL, MA, MD, MN, NJ, PA, TX

Quantity Affected

2,459 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1534-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.