Smith & Nephew recalls certain Journey II XR Tibial Posterior Keel Punches due to higher than expected bone fracture risk during use. Affected units have specific batch numbers. Consumers should contact the company for details.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Smith & Nephew is recalling certain Journey II XR Tibial Posterior Keel Punches because they can cause bone fractures during use. This recall affects specific batch numbers of the surgical instrument used in orthopedic procedures.
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 in orthopedic surgery.
Orthopedic surgeons and medical professionals who use the Journey II XR Tibial Posterior Keel Punch for surgical procedures are most at risk. Patients receiving this surgery may also be affected if the instrument is used improperly.
Check the batch numbers on the instrument: 17JGA0021, 17JGA0021A, 17JGA0027, 17JGA0027A, 17JGA0027B, 17JGA0033A, 17JGA0033B, 17JGA0043, 17JGA0043A, 17JGA0043B, 17JGA0043R, 17JGA0047, and 18BGA0014B.
Look for batch numbers on the instrument: 17JGA0021, 17JGA0021A, 17JGA0027, 17JGA0027A, 17JGA0027B, 17JGA0033A, 17JGA0033B, 17JGA0043, 17JGA0043A, 17JGA0043B, 17JGA0043R, 17JGA0047, and 18BGA0014B.
The hazard is a higher than anticipated occurrence of bone fracture during use of the XR Tibia Posterior Punch in orthopedic surgery.
Affected batch numbers are: 17JGA0021, 17JGA0021A, 17JGA0027, 17JGA0027A, 17JGA0027B, 17JGA0033A, 17JGA0033B, 17JGA0043, 17JGA0043A, 17JGA0043B, 17JGA0043R, 17JGA0047, and 18BGA0014B.
The recall does not specify a remedy, so contact Smith & Nephew directly for instructions on next steps.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1043-2019 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1043-2019 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.
