DePuy recalls Attune Revision Limb Preservation System Tibial Insert XXSM 18MM with higher radiation dose that may alter implant material. Affected units have specific part number and lot code.
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 due to radiation exposure that could change its material properties. This affects patients who received this implant during the specified production period.
The implant received a higher than specified radiation dose during manufacturing. This exceeds the validated range for gamma radiation exposure and could cause changes to the implant material properties over time.
Patients who received the Attune Revision Limb Preservation System Tibial Insert XXSM 18MM with part number 151760118 during the production period are affected. The risk is low as the hazard is related to material changes rather than immediate injury.
Check for part number 151760118 and lot code JP6452 on the implant. The product was sold with GTIN 10603295491095 during the production period.
Look for part number 151760118 and lot code JP6452 on the implant.
The implant received a higher than specified radiation dose during manufacturing, which may cause changes to the implant material properties.
Check the part number and lot code on the implant. If it matches 151760118 and JP6452, contact DePuy for further instructions.
The recall is for potential material changes over time, not an immediate risk of serious injury. The hazard level is low risk.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-1263-2023 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-1263-2023 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.
