Novosource recalls NovoHip Biolox Ball Head 32mmL (Ref: 1345-2:803) due to mislabeling that could cause joint instability if implanted. Affected units include specific lot numbers and model.
Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
Novosource is recalling NovoHip Biolox Ball Head 32mmL implants because they were mislabeled as 32mm but are actually 28mm. This mismatch could cause joint instability if used in hip replacements.
The ball head is labeled as 32mm but is actually 28mm. This size mismatch can cause joint instability during hip replacement surgery if the implant is not properly sized.
Patients who received the NovoHip Total Hip System with the mislabeled ball head (32mm labeled but 28mm actual) are affected. Surgeons and patients using this specific model are most at risk.
Check for the product name 'NovoHip Biolox Ball Head 32mmL' with reference number 1345-2803. Affected units have lot number CER0023.
Verify the product name, reference number, and lot number to confirm if your unit is affected.
The NovoHip Biolox Ball Head 32mmL was mislabeled as 32mm but is actually 28mm, which could cause joint instability if implanted.
Check the product name, reference number, and lot number to see if it's affected. If so, contact Novosource for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Novosource to request your refund or repair — edit it as you like.
Subject: Recall Z-0483-2025 — Novosource Novosource Hello, I own a Novosource that is covered by recall Z-0483-2025 from Novosource. 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.
