Howmedica Osteonics recalls Biolox delta Ceramic V40 Femoral Head 32/-4.0mm (Lot 89648802) due to potential size/offset mismatch with labeling. Affected customers should contact for details.
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
Howmedica Osteonics is recalling Biolox delta Ceramic V40 Femoral Heads that may have incorrect size or offset compared to their packaging. This mismatch could lead to improper fitting during hip replacement surgery, potentially causing complications.
The product may have a size or offset that doesn't match the packaging label. This could result in improper fitting during hip replacement surgery, potentially causing complications like improper joint alignment or instability.
Patients who received the Biolox delta Ceramic V40 Femoral Head 32/-4.0mm (Lot 89648802) for hip replacement surgery. Surgeons and medical facilities using this specific model are most at risk.
Check for the product name 'Biolox delta Ceramic V40 Femoral Head 32/-4.0mm' with Catalog Number 6570-0-032. Lot Number 89648802 is the affected batch; other lots were removed from the recall.
Reach out to Howmedica Osteonics for specific instructions on whether your product is affected and next steps.
The recall indicates a potential mismatch in size/offset, but the product is not unsafe for use unless it has the specific affected lot number. Affected customers should contact the manufacturer.
Lot 89648802 is the affected lot number; other lots were removed from the recall scope.
Check for the product name 'Biolox delta Ceramic V40 Femoral Head 32/-4.0mm' with Catalog Number 6570-0-032 and Lot Number 89648802.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0842-2022 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0842-2022 from Howmedica Osteonics. 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.