PlainRecalls
FDA Devices Moderate Class II Terminated

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040

Reported: July 11, 2018 Initiated: May 22, 2018 #Z-2293-2018

Product Description

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040

Reason for Recall

The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.

Details

Recalling Firm
Howmedica Osteonics Corp.
Distribution
Distributed nationwide. Foreign distribution 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 United Kingdom.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040. Recalled by Howmedica Osteonics Corp..
Why was this product recalled?
The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 11, 2018. Severity: Moderate. Recall number: Z-2293-2018.