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 involves a medical device with a risk of harm (disassociation) where injury has not yet been explicitly reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144. The recall covers specific lots of femoral heads manufactured prior to March 4, 2011.
The recall was initiated because the firm received a higher than expected number of complaints documenting femoral head and hip stem disassociation for certain sizes of these devices. The affected products were distributed nationwide and to various foreign countries, including Australia, Canada, and the United Kingdom.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the official recall notice. If a patient has one of the affected devices, they should contact their healthcare provider for evaluation and appropriate management.
The recalled product
- Product
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
- 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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