DePuy recalls specific Sigma HP cemented trochlear implants due to higher-than-expected revision rates observed in post-market use. Affected products include left and right narrow sizes 1-5 with catalog numbers 102403100-102404500.
The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.
DePuy is recalling specific Sigma HP cemented trochlear implants for knee replacements because they have higher-than-expected revision rates. This means some implants may need to be replaced sooner than expected, which could lead to additional surgery or complications.
The recall is based on post-market surveillance showing more frequent revisions (removals and replacements) than expected for these implants. This suggests the implants may not be lasting as long as intended, potentially requiring additional surgery.
Patients who received one of the recalled implant models during surgery are most at risk. The recall applies to specific left and right knee implant sizes used in partial knee replacements.
Check if your implant has a catalog number starting with 102403100 to 102404500 or a GTIN starting with 10603295001614 to 10603295001706. The recall covers all lots of these specific implant models.
Review your implant's catalog number and GTIN to confirm if it matches the recalled models listed in the notice.
DePuy identified higher-than-expected revision rates for these implants through post-market surveillance, indicating they may not last as long as intended.
The recall does not require immediate action. Patients should check their implant details to confirm if it is affected, but no action is needed unless the implant is part of the recalled models.
Check your implant's catalog number (102403100-102404500) or GTIN (10603295001614-10603295001706) against the list provided in the recall notice.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-1219-2018 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-1219-2018 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.
