Smith & Nephew recalls TRIGEN intramedullary nails with a manufacturing error causing improper re-sterilization of the UHMWPE sleeve. Affected models include 71655139 lot 19BM13592A.
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Smith & Nephew is recalling TRIGEN intramedullary nails due to a manufacturing error that may have caused improper re-sterilization of the UHMWPE sleeve. This could affect the nail's performance during surgery.
The manufacturing error could have caused improper re-sterilization of the UHMWPE sleeve, which is critical for the nail's function during surgery. This might lead to the nail not providing adequate resistance for screw back-out, potentially causing complications during orthopedic procedures.
Surgical patients who received the recalled TRIGEN intramedullary nail model 71655139 with lot number 19BM13592A. Surgeons and medical staff using these nails for orthopedic procedures are most at risk.
Check for the model number 71655139 and lot number 19BM13592A on the TRIGEN intramedullary nail packaging or label. This recall applies to specific surgical implants used in orthopedic procedures.
Verify the model number 71655139 and lot number 19BM13592A on the TRIGEN intramedullary nail.
Smith & Nephew identified a manufacturing error that resulted in improper re-sterilization of the UHMWPE sleeve in the TRIGEN intramedullary nail.
The official recall notice does not specify a remedy or action steps for affected products.
The recall indicates a potential issue with the manufacturing process, but the official notice does not state if the product is unsafe to use.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2685-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2685-2020 from Smith & Nephew. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
