Smith & Nephew recalls JOURNEY II Uni Resection Prep Trial surgical instruments with a spike rail defect that could cause the device to disassemble during use. Affected units include specific sizes and batch codes.
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
Smith & Nephew is recalling JOURNEY II Uni Resection Prep Trial surgical instruments because a manufacturing defect in the spike rail could cause the device to disassemble during surgery. This poses a risk of improper joint alignment and potential complications for patients.
The spike rail has an oversized thru-hole that can cause the dowel pin to fall out. This may lead to the device disassembling during surgery, potentially causing improper joint alignment and surgical complications.
Surgical professionals who use the JOURNEY II Uni Resection Prep Trial instruments for joint assessments are most at risk. Patients undergoing surgery with these instruments may face alignment issues.
Check the catalog number (REF 74035831-74035840) and batch codes listed for each size. The affected units include specific batch codes like 19FM01064R, 19HM18082, and others listed in the recall notice.
Identify the catalog number (REF 74035831-74035840) and batch codes for your instrument to confirm if it's affected.
The spike rail was manufactured with an oversized thru-hole that could cause the dowel pin to fall out and the device to disassemble during surgery.
The recall notice does not specify a remedy, so check the product details to confirm if it's affected and contact Smith & Nephew for further instructions.
Affected sizes have catalog numbers REF 74035831-74035840 with specific batch codes listed for each size in the recall notice.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2133-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2133-2020 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.
