Smith & Nephew recalls TRIGEN Proximal Straight Humeral Nail 8/7 X 16 with missing distal holes that may require revision surgery. Affected units have specific lot numbers and UDI-DI codes.
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Smith & Nephew is recalling a specific type of humeral nail due to a manufacturing error that causes missing distal holes. If implanted without checking, this could lead to revision surgery. However, identifying the missing holes before implantation allows for a backup solution.
The humeral nail has missing distal holes due to a manufacturing error. If implanted without identifying the missing holes, it may require revision surgery. However, checking for missing holes before implantation allows for a backup solution to avoid surgery delays.
Orthopedic surgeons and medical facilities using the TRIGEN Proximal Straight Humeral Nail 8/7 X 16 with lot number 25BM03616 are affected. Patients undergoing hip or shoulder surgery are at risk if the nail is implanted without checking for missing holes.
Check for the product name 'TRIGEN Proximal Straight Humeral Nail 8/7 X 16' with UDI-DI code 03596010514394 and lot number 25BM03616. This specific model was sold with these identifiers.
Inspect the nail for missing distal holes before implantation to determine if a backup solution is needed.
The humeral nail has missing distal holes due to a manufacturing error, which could lead to revision surgery if not identified before implantation.
Check for missing distal holes before implantation. If identified, use a backup solution to avoid revision surgery.
The recall states that if the missing holes are not identified before implantation, it may require revision surgery, but does not mention immediate injury risks.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2456-2026 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2456-2026 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.
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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.
