Surgical Specialties recalls POLYSIN (Polyglycolic Acid) suture model G503N due to reported incorrect needle curvature. Affected units include specific lot codes and part numbers.
Complaints have been received with allegations of Incorrect Needle Curvature.
Surgical Specialties is recalling POLYSIN (Polyglycol: 5-0 BR PGA) sutures with part number G503N because complaints indicate incorrect needle curvature. This could lead to improper surgical procedures if the suture is used.
Incorrect needle curvature may cause the suture to behave unpredictably during surgery, potentially leading to complications like tissue damage or improper wound closure. This could affect the safety and effectiveness of the procedure.
Surgical professionals using the POLYSIN suture model G503N with specific lot codes are affected. Surgeons and medical staff who have this product in their inventory or are planning to use it are at risk.
Check for the model number G503N and lot codes C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, or DA26LQG on the suture packaging or labels.
Verify the model number and lot codes on the suture packaging to confirm if it is affected.
The recall is based on complaints of incorrect needle curvature, but the official notice does not specify if the suture is safe when used correctly.
The recall record does not provide a remedy, so no specific action is required beyond checking product details.
Affected lot codes are C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, and DA26LQG.
We’ve drafted a message you can send Surgical Specialties to request your refund or repair — edit it as you like.
Subject: Recall Z-1534-2024 — Surgical Specialties Surgical Specialties Hello, I own a Surgical Specialties that is covered by recall Z-1534-2024 from Surgical Specialties. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
