FDA recall Z-2348-2021

Product

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Reason for recall

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

Distribution

International distribution in the countries of Canada, France.

Key facts

Status

Terminated

Initiation date

2021-07-01

Report date

2021-09-01

Termination date

2023-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2348-2021