DePuy recalls Attune Posterior Tibial Insert SZ5 7MM with higher-than-specified gamma radiation dose. This may alter implant material properties. Affected units have part number 151640507 and lot JN6613.
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 Attune Posterior (PS) Fixed Bearing Tibial Inserts SZ5 7MM with part number 151640507 due to potential material changes from excessive gamma radiation exposure. This could affect implant performance and safety after surgery.
The implant received higher than specified gamma radiation during manufacturing. This may cause changes to the implant material properties, potentially affecting its performance and safety after surgery.
Patients who received this specific implant during surgery are most at risk. The recall applies to the exact model and lot number produced.
Check for part number 151640507 and lot number JN6613 on the implant. This specific model was manufactured with a higher radiation dose than approved.
Look for part number 151640507 and lot number JN6613 on the implant.
The implant received a higher than specified irradiation dose during manufacturing, which may cause changes to the implant material properties.
Check for part number 151640507 and lot number JN6613 on the implant. If you have this specific model, contact DePuy Orthopaedics for further instructions.
The recall is for potential material changes from excessive radiation, but the risk is low as the implant is only affected by specific manufacturing conditions.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-1267-2023 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-1267-2023 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.
