Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation
Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (disassociation) in an implanted medical device, which poses a significant risk of injury and aligns with the 'Severe' criteria for structural defects and significant injury reports.
Plain-English summary
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040. The recall covers specific sizes of femoral heads manufactured prior to March 4, 2011. The affected lots are distributed nationwide and in multiple foreign countries, including Australia, Canada, and the United Kingdom.
The recall was initiated after the firm received a higher than expected number of complaints documenting femoral head and hip stem disassociation. This defect involves the separation of the femoral head from the hip stem component.
Healthcare providers and patients should check their inventory and medical records to determine if they are using or have received the affected lots. If the product is identified, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority.
The recalled product
- Product
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
- Manufacturer
- Howmedica Osteonics Corp.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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