The Recall Desk
HighFDA (Devices)·Z-2298-2018·Announced 2018-07-11

Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding 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 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 or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336. The recall involves specific lots of these medical devices, which are distributed nationwide and in various foreign countries including Australia, Canada, and the United Kingdom.

The recall was initiated after the firm received a higher than expected number of complaints documenting femoral head/hip stem disassociation. This issue affects certain sizes of femoral heads that were manufactured prior to March 4, 2011. The source text does not specify the exact number of affected units or the specific sizes involved.

Patients with these implants should contact their healthcare provider for evaluation and guidance. 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, Catalog No. 6260-9-336

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 →