DePuy recalls Attune Revision Limb Preservation Tibial Insert XSM 12MM (part 151760212) due to potential material changes from excessive gamma radiation exposure during manufacturing.
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
DeP:uy Orthopaedics is recalling a specific type of knee implant because it may have been exposed to too much gamma radiation during production. This could cause the implant material to change, potentially affecting its safety and performance in the body.
The implant received a higher than specified dose of gamma radiation during manufacturing. This exceeds the validated range for these devices and may cause changes to the implant material properties, potentially affecting its performance in the body.
Patients who received this specific knee implant part (part number 151760212) during surgery are likely affected. Those with the implant are at risk if the material changes could impact long-term function.
Check if your knee implant has the part number 151760212 and lot number JP9016. The product was sold with GTIN 10603295490968.
Identify if your implant matches part number 151760212 and lot number JP9016.
The recall indicates potential material changes from excessive radiation, but the product is not immediately dangerous. Patients should consult their surgeon for guidance.
Check for part number 151760212 and lot number JP9016 on your implant. The product was sold with GTIN 10603295490968.
The recall does not specify a remedy, so contact your surgeon to discuss potential next steps.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-1264-2023 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-1264-2023 from DePuy. 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.
