DePuy Orthopaedics recalls Attune Revision Limb Preservation Tibial Insert SM 12MM (part 151760312) due to potential radiation exposure affecting implant material. Affected lots may require replacement.
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 Orthopaedics is recalling a specific type of knee implant component because it received too much radiation during manufacturing. This could change the implant's material properties, potentially causing problems later.
The implant received a higher radiation dose than specified during manufacturing. This may alter the material properties of the implant, which could lead to issues with its performance in the body over time.
People who own or use the Attune Revision Limb Preservation System Tibial Insert SM 12MM (part number 151760312) are affected. Those with this implant in their knee surgery are most at risk.
Check for the part number 151760312 on the implant. The affected lot number is JP6464. This product was sold with the GTIN 10603295490869.
Look for the part number 151760312 and lot number JP6464 on the implant.
The recall is for potential material changes due to radiation, but the implant is not immediately dangerous. Consult your surgeon for specific advice.
The recall does not require immediate replacement. Contact DePuy Orthopaedics for guidance if you have the affected product.
Check the part number 151760312 and lot number JP6464 on the implant. The GTIN is 10603295490869.
We’ve drafted a message you can send DePuy Orthopaedics to request your refund or repair — edit it as you like.
Subject: Recall Z-1266-2023 — DePuy Orthopaedics DePuy Orthopaedics Hello, I own a DePuy Orthopaedics that is covered by recall Z-1266-2023 from DePuy Orthopaedics. 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.