Reported Apr 24, 2024 · Ongoing

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

Surgical Specialties

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SURGICAL SPECIALTIES · 247 Station Dr · Westwood, MA · 02090-2396

Is this the product you have?

  • POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Lot codes and dates
  • Model Number G503N
  • UDI00848782015115
  • Lot Codes
    • C318TXK
    • C902CCF
    • D413FLD
    • D524ZOU
    • C725TAC
    • D215GJN
    • D503OCB
    • DA26LQG
Amount recalled
2,459 units

Where it was sold

Why it was recalled

Complaints have been received with allegations of Incorrect Needle Curvature.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

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