Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and 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 and involves a risk-of-harm product (medical device disassociation) where specific injury counts or fatalities are not explicitly 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. 6260-9-044. The recall covers specific lots 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 and hip stem disassociation for certain sizes of the affected femoral heads. The products were distributed nationwide and to multiple foreign countries, including Australia, Canada, and the United Kingdom.
Patients who have had these specific femoral heads implanted should contact their healthcare provider to discuss the recall and potential next steps. The source text does not specify a particular action for consumers to take other than the context of the medical device recall.
The recalled product
- Product
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
- 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.
See all 8 products in this recall →Related recalls
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