FDA recall Z-2250-2021

Exactech, Inc. · Class II · device

Product

Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

Reason for recall

Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).

Distribution

US Nationwide Distribution

Key facts

Status
Completed
Initiation date
2021-06-29
Report date
2021-08-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2021