FDA recall Z-2292-2018

Product

LFIT Anatomic CoCr Femoral Heads, 6260-9-036

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.

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.

Key facts

Status

Terminated

Initiation date

2018-05-22

Report date

2018-07-11

Termination date

2020-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2018