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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

SURGICAL SPECIALTIES: POLYSIN (Polyglycolic Acid) Sutures Recalled for Incorrect Needle Curvature

Agency Publication Date: April 12, 2024
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Summary

Surgical Specialties is recalling 2,459 units of POLYSIN (Polyglycolic Acid) sutures, model HSM9 5-0 BR PGA. The recall was initiated following complaints that the needles have an incorrect curvature, which does not meet manufacturing specifications. This defect affects model number G503N and specifically involves eight specific lot codes distributed across several U.S. states and New Zealand.

Risk

An incorrect needle curvature can cause difficulty during surgical procedures, potentially leading to tissue trauma, prolonged surgery time, or improper wound closure. The manufacturer has received complaints regarding this specific defect.

What You Should Do

  1. Check your medical supplies for POLYSIN (Polyglycolic Acid) sutures, specifically model number G503N with UDI 00848782015115.
  2. Verify if your product matches one of the following affected lot codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, or DA26LQG.
  3. Immediately stop using any sutures identified with these specific lot codes and quarantine them to prevent clinical use.
  4. Contact your healthcare provider or Surgical Specialties directly to discuss the return of affected products and to obtain information regarding replacements or potential refunds.
  5. For additional information or questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and coordination for defective medical device

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA
Model / REF:
G503N
UPC Codes:
00848782015115
Lot Numbers:
C318TXK
C902CCF
D413FLD
D524ZOU
C725TAC
D215GJN
D503OCB
DA26LQG

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94237
Status: Active
Manufacturer: SURGICAL SPECIALTIES
Sold By: Surgical Specialties
Manufactured In: United States
Units Affected: 2,459 units
Distributed To: Arizona, California, Illinois, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.