Howmedica Osteonics recalls Biolox delta Ceramic V40 Femoral Heads 32/ +4.0mm (Catalog 6570-0-232) due to potential size/offset mismatch with labeling. Affected units may have incorrect dimensions for surgical use.
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 32/ +4.0mm (Catalog 6570-0-232) because the actual size and offset might not match the package labels. This mismatch could lead to improper surgical implantation if used without verification.
The recall addresses a potential mismatch between the labeled dimensions and the actual size/offset of the femoral head. If the implant is used without verifying the correct specifications, it could lead to improper surgical fitting during hip replacement procedures.
Orthopedic surgeons and medical facilities that use these specific femoral heads for hip replacements. Patients receiving these implants are not directly affected by the recall.
Check for the catalog number 6570-0-232 on the packaging. The lot number 89546202 and GTIN (01)04546540608536(17)261020(10)89546202 are also associated with this specific batch.
Check the package for the catalog number 6570-0-232 and lot number 89546202 to confirm it matches the recalled item.
No, patients who have already received the implant are not affected by this recall as it pertains to the surgical implant's labeling during use.
Look for the catalog number 6570-0-232 and lot number 89546202 on the packaging to identify affected units.
The recall does not specify a remedy, so you should verify the product's labeling to ensure it matches the recalled specifications.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0843-2022 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0843-2022 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.
