Smith & Nephew recalls LAG screw 3.2mm guide pin sleeves (ref 71674032) due to manufacturing error causing detent balls to not fully compress. Affected batch numbers include 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A.
LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.
Smith & Nephew is recalling LAG screw 3.2mm guide pin sleeves (ref 71674032) because a manufacturing error means the detent balls won't fully compress. This could lead to improper nail fixation during fracture treatment, potentially causing complications in orthopedic procedures.
The detent balls in the guide pin sleeve were not drilled to the correct depth during manufacturing. This prevents them from fully compressing, which could result in improper nail fixation during fracture treatment. The risk is primarily for medical procedures involving the femur.
Orthopedic surgeons and medical professionals who use the TRIGEN InterTAN nails for femur fractures are most at risk. Patients receiving these nails may be affected if they have the recalled product.
Check for the product name 'LAG SCREW 3.2MM GUIDE PIN SLEEVE' with reference number 71674032. Affected batch numbers are 18DM11613A, 18HM02575, 18HM13327A, and 18HM20956A.
Identify the batch number on the product label to determine if it matches the affected batches: 18DM11613A, 18HM02575, 18HM13327A, or 18HM20956A.
The detent balls were not drilled to the correct depth, which prevents them from fully compressing.
The TRIGEN InterTAN nails are used for femur fractures including simple shaft fractures, comminuted shaft fractures, and other specific fracture types.
Check for the reference number 71674032 and affected batch numbers: 18DM11613A, 18HM02575, 18HM13327A, or 18HM20956A.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0351-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0351-2020 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.
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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.
