Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about disassociation from the hip stem.
What this means for you
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: The recall involves a risk-of-harm product (medical device disassociation) where injury has not yet been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236. The recall involves specific lots of these medical devices that were distributed nationwide and to various foreign countries including Australia, Canada, and the United Kingdom.
The recall was initiated because the firm received a higher than expected number of complaints documenting femoral head/hip stem disassociation. This issue affects certain sizes of femoral heads manufactured prior to March 4, 2011. The source text does not specify the exact number of affected units or the specific sizes involved.
Healthcare providers and patients should check their inventory and patient records for the affected lot numbers listed in the official recall notice. If a patient has an affected device, they should contact their healthcare provider for guidance on monitoring or potential replacement.
The recalled product
- Product
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
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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