FDA recall Z-1703-2018

Product

ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

Reason for recall

There may be burrs on the extraction hole threads.

Distribution

The products were distributed to the following US states: FL, MO, and PA.

Key facts

Status

Terminated

Initiation date

2018-04-16

Report date

2018-05-16

Termination date

2019-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2018