Smith & Nephew recalls JOURNEY II XR Tibial Posterior Keel Punch models with batch numbers 17JGA0023 to 17JGA0045R due to higher than expected bone fracture risk during use.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Smith & Nephew is recalling specific models of their JOURNEY II XR Tibial Posterior Keel Punch surgical instruments because they can cause bone fractures during use. This recall affects surgeons and medical professionals who use these instruments for tibial baseplate preparation.
The JOURNEY II XR Tibial Posterior Keel Punch has been found to cause higher than expected bone fractures during surgical procedures. This risk occurs when the instrument is used to prepare the tibia for a tibial baseplate.
Surgeons and medical professionals who use the JOURNEY II XR Tibial Posterior Keel Punch for tibial baseplate preparation are most at risk. The recall applies to specific batch numbers of this surgical instrument.
Check the batch number on the instrument, which is listed as 17JGA0023, 17JGA0023A, 17JGA0023C, 17JGA0029, 17JGA0029A, 17JGA0029B, 17JGA0035A, 17JGA0035C, 17JGA0045B, 17JGA0045C, 17JGA0045D, or 17JGA0045R.
Look for the batch number on the instrument, which is one of the listed codes: 17JGA0023, 17JGA0023A, 17JGA0023C, 17JGA0029, 17JGA0029A, 17JGA0029B, 17JGA0035A, 17JGA0035C, 17JGA0045B, 17JGA0045C, 17JGA0045D, or 17JGA0045R.
It is a reusable surgical instrument used to prepare the proximal tibia for receiving a JOURNEY II XR tibial baseplate.
Batch numbers 17JGA0023, 17JGA0023A, 17JGA0023C, 17JGA0029, 17JGA0029A, 17JGA0029B, 17JGA0035A, 17JGA0035C, 17JGA0045B, 17JGA0045C, 17JGA0045D, and 17JGA0045R.
The recall record does not specify a remedy.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1045-2019 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1045-2019 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.
