FDA-Device2024-04-24Class II
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
SURGICAL SPECIALTIES
Hazard
Complaints have been received with allegations of Incorrect Needle Curvature.
Sold states
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Affected count
2,459 units
Manufactured in
247 Station Dr, Westwood, MA, United States
Products
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2024Don't want to check this manually?
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