Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation Complaints
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to higher-than-expected complaints of femoral head/hip stem disassociation.
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 certain lots of LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136. The recall involves specific sizes of femoral heads manufactured prior to March 4, 2011.
The firm initiated the recall after receiving a higher than expected number of complaints documenting femoral head/hip stem disassociation. The affected products were distributed nationwide and to numerous foreign countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
Patients with these implants should contact their healthcare provider for evaluation. The recall covers a specific list of lot numbers provided in the official FDA notice.
The recalled product
- Product
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
- 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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