Smith & Nephew recalls certain Journey II XR Tibial Posterior Keel Punches (sizes 5-6) due to higher than expected bone fracture risk during use. Affected units have specific batch numbers listed in the recall notice.
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 (sizes 5-6) because they may cause bone fractures during surgery. This recall affects specific batch numbers of the surgical instrument used in orthopedic procedures.
The JOURNEY II XR Tibial Posterior Keel Punch is a surgical instrument used to prepare the tibia for a tibial baseplate. Higher than anticipated bone fractures can occur during use, potentially leading to complications in orthopedic surgery.
Surgical professionals using the Journey II XR Tibial Posterior Keel Punch for orthopedic procedures are most at risk. Patients receiving this surgical instrument may also be affected if the punch causes bone fractures.
Check the batch numbers on the punch: 17JGA0022, 17JGA0022A, 17JGA0022B, 17JGA0028, 17JGA0028A, 17JGA0028B, 17JGA0034A, 17JGA0034C, 17JGA0044, 17JGA0044B, 17JGA0044R, 18BGA0015A, and 18BGA0015B.
Identify the batch numbers on the punch: 17JGA0022, 17JGA0022A, 17JGA0022B, 17JGA0028, 17JGA0028A, 17JGA0028B, 17JGA0034A, 17JGA0034C, 17JGA0044, 17JGA0044B, 17JGA0044R, 18BGA0015A, and 18BGA0015B.
The JOURNEY II XR Tibial Posterior Keel Punch may cause higher than anticipated bone fractures during use in orthopedic procedures.
Affected batch numbers include: 17JGA0022, 17JGA0022A, 17JGA0022B, 17JGA0028, 17JGA0028A, 17JGA0028B, 17JGA0034A, 17JGA0034C, 17JGA0044, 17JGA0044B, 17JGA0044R, 18BGA0015A, and 18BGA0015B.
The recall does not require stopping use; the hazard is a potential bone fracture risk during surgery, which is considered low risk for the general population.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1044-2019 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1044-2019 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.
