Medical device recalls Moderate risk

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

Recall date
March 26, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1534-2024
FDA classification
Class II
Brand / firm
SURGICAL SPECIALTIES
Sold / distributed
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.

Why it was recalled

Complaints have been received with allegations of Incorrect Needle Curvature.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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