DePuy recalls specific lots of Sigma RP Mobile Bearing Total Knee System components due to potential damaged packaging. Affected tibial bases are used in cemented knee replacements. Consumers should check lot numbers and contact DePuy for details.
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
DePuy is recalling certain lots of Sigma RP Mobile Bearing Total Knee System components because of potential damaged packaging. This could affect the safety of the implant components used in cemented knee replacements. Affected customers should check their lot numbers and contact DePuy for instructions.
The recall is due to potential damaged packaging in specific lots of tibial bases. These components are used in cemented knee replacements, where proper packaging is critical to prevent contamination or damage during surgery. Damaged packaging could lead to compromised implant integrity.
Patients who received the recalled lots of Sigma RP Mobile Bearing Total Knee System components for cemented knee replacements are affected. Surgeons and medical facilities using these specific lot numbers are at the highest risk.
Check the lot numbers: 9543538, 9553989, 9554547, 9554548, 9554551, 9548774, 9548777, or 9554569. The product code is 129433130 or 129433140, and the GTIN is 10603295025788 or 10603295025795.
Compare your product's lot number to the listed affected lots: 9543538, 9553989, 9554547, 9554548, 9554551, 9548774, 9548777, or 9554569.
DePuy is recalling specific lots of Sigma RP Mobile Bearing Total Knee System components due to potential damaged packaging, which could affect the safety of the implant components used in cemented knee replacements.
Check your product's lot number against the affected lots listed. Contact DePuy directly for further instructions.
The recall is for potential damaged packaging, which could lead to compromised implant integrity during surgery, but the risk is low as the product is used in cemented knee replacements.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-1315-2021 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-1315-2021 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.
