Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2251-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

Product Classification:

Class II

Date Initiated: June 29, 2021

Date Posted: August 18, 2021

Recall Number: Z-2251-2021

Event ID: 88259

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).

Status: Completed

Product Quantity: 30 devices

Code Information:

Serial Numbers: 6465619-6465640; 6465642-6465648

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated