Ceramic Hip Femoral Head Component May Not Match Package Label
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving an orthopedic implant component with a product-to-label mismatch that could compromise implant integrity. No illnesses or injuries have been reported, limiting the score to 3 per the rubric criterion that theoretical hazards without reported harm score at most 3.
Plain-English summary
Howmedica Osteonics Corp. is recalling certain Biolox delta Ceramic V40 Femoral Head components (Catalog Number 6570-0-032) used in hip replacement surgery. Specifically, 40 units of lot number 89648802 are affected.
The femoral head component inside the package may not match the size and offset specifications printed on the package label. If a mismatched component is implanted, it may not fit correctly with the associated hip implant system, potentially compromising the integrity and longevity of the implant.
The affected units were distributed worldwide to patients in the United States, Canada, China, Japan, the United Kingdom, and the Netherlands. Healthcare providers and patients who may have received these components should review the lot number on the package.
Patients who have received implants with these components should contact their surgeon or healthcare provider to discuss whether their implant is affected and what steps, if any, are necessary.
The recalled product
- Product
- Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
- Manufacturer
- Howmedica Osteonics Corp.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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