Smith & Nephew recalls JOURNEY II Uni Resection Prep Trial surgical instruments with a spike rail that may disassemble due to an oversized thru-hole. Affected models include sizes 1-10 with specific lot 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 spike rail defect could cause the device to disassemble during use. This poses a risk of improper surgical fixation if the instrument fails.
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 fixation and affecting surgical outcomes.
Surgical professionals using the JOURNEY II Uni Resection Prep Trial instruments for joint surgery are most at risk. Patients undergoing procedures with these instruments may be affected if the device disassembles during surgery.
Check for the product name 'JOURNEY II Uni Resection Prep Trial' with sizes 1-10. Look for catalog numbers REF 74035821-30 and specific lot/batch codes listed in the recall notice.
Identify the size, catalog number, and lot/batch code to confirm if your instrument is affected.
The recall states the spike rail defect could cause disassembly during use, so it is not safe to use without checking if it's affected.
The recall does not specify a remedy, so contact Smith & Nephew directly to determine if your specific model is affected.
Check for the catalog numbers REF 74035821-30 and specific lot/batch codes listed 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-2132-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2132-2020 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.
