Z-2250-2021 Class II

Recalled by Exactech, Inc. — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
August 18, 2021
Initiation Date
June 29, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29 devices

Product Description

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 Pattern

US Nationwide Distribution

Code Information

Serial Numbers: 6465589-6465618; 6465641