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 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: The recall is classified as FDA Class II. The hazard involves a structural failure (disassociation) of an implanted medical device, which poses a risk of harm, but the source text does not report specific injuries, hospitalizations, or deaths, placing it in the High severity category per the rubric.
Plain-English summary
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads, catalog number 6260-9-036. The recall involves specific sizes of femoral heads manufactured prior to March 4, 2011. The company initiated the recall after receiving a higher than expected number of complaints documenting femoral head and hip stem disassociation.
The affected products were distributed nationwide in the United States and internationally to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. The source text does not specify the total number of units affected or the exact number of complaints received.
Patients with these implants should contact their healthcare provider for evaluation. The source text does not provide specific consumer instructions beyond the general context of a medical device recall.
The recalled product
- Product
- LFIT Anatomic CoCr Femoral Heads, 6260-9-036
- 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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