FDA recall Z-2267-2018

Product

Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156

Reason for recall

The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US

Distribution

OH, TX, CO, TN, MI, PA, NJ

Key facts

Status

Terminated

Initiation date

2018-05-11

Report date

2018-06-27

Termination date

2019-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2267-2018