Exactech, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0012-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

Product Classification:

Class II

Date Initiated: August 21, 2018

Date Posted: October 10, 2018

Recall Number: Z-0012-2019

Event ID: 80996

Reason for Recall:

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

Status: Ongoing

Product Quantity: 2 units

Code Information:

Serial Numbers: 5214432, 5214445

Distribution Pattern:

In the countries of Australia and France

Voluntary or Mandated:

Voluntary: Firm initiated