Smith & Nephew recalls Legion HK Femoral Wedge (Wedge and Screw) 5mm size due to screws being 5mm instead of 10mm, which can't be used with the device. Affected items have batch number 14AAP6352A.
The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
Smith & Nephew is recalling a specific femoral wedge implant because the screws included are too short (5mm instead of 10mm) and won't work with the device. This could lead to improper implantation and potential complications during surgery.
The screws in the recalled batch are 5mm instead of the required 10mm size. This mismatch means the screws won't properly secure the device, which could cause improper implantation during surgery and potential complications.
Patients who received the Legion HK Femoral Wedge (Wedge and Screw) with batch number 14AAP6352A for revision knee surgery. Surgeons and medical staff who used this specific implant are most at risk.
Check for the batch number 14AAP6352A on the packaging of the Legion HK Femoral Wedge (Wedge and Screw) 5mm, Size 5, REF 71422159. This product is used in revision knee surgery for specific patient conditions.
Look for the batch number 14AAP6352A on the packaging of the Legion HK Femoral Wedge (Wedge and Screw) 5mm, Size 5, REF 71422159.
The screws in this batch are 5mm instead of the required 10mm size, which means they won't work with the device and could cause improper implantation during surgery.
The official recall notice does not specify a remedy or action for affected items.
The product is not safe to use as the screws are the wrong size, which could lead to improper implantation and potential complications.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1105-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1105-2018 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.
