DePuy recalls Attune Revision Limb Preservation Tibial Insert XSM 26MM (Part 151760226) due to potential radiation dose issues affecting implant safety. Learn about affected products and required actions.
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.
DePuy is recalling a specific type of knee implant because it received too much radiation during manufacturing. This could change the implant's material properties and potentially cause safety issues during use.
The implant received a higher than specified radiation dose during manufacturing. This exceeds the validated range for gamma radiation exposure, which could alter the implant's material properties. If these changes occur, they might cause safety issues during use.
People who own or use the recalled Attune Revision Limb Preservation System Tibial Insert XSM 26MM (Part Number 151760226) are affected. Those with this specific implant are most at risk.
Check for the Part Number 151760226 on the implant. The product was sold with Lot Number JP9022 and GTIN 10603295491033.
Identify the Part Number 151760226 and Lot Number JP9022 on the implant.
The product received a higher than specified radiation dose during manufacturing, which may change the implant material properties.
The official recall notice does not specify any action steps for affected users.
The recall states potential changes to implant material properties, but does not specify a risk of serious injury.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-1265-2023 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-1265-2023 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.