Recall Z-0012-2019— Exactech, Inc.

Name: FDA recall Z-0012-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-21

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2018-08-21. It names one FDA 510(k) clearance: K063569. Product: Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery. Reason: 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..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2018-08-21
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K063569 — EQUINOXE REVERSE SHOULDER SYSTEMExactech, Inc.·cleared 2007-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.