Recall Z-0900-2017— Exactech, Inc.

Name: FDA recall Z-0900-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-25

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2016-10-25, terminated 2019-07-26. It names one FDA 510(k) clearance: K063569. Product: Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit. Reason: Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-25
Terminated: 2019-07-26
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 Shoulder Fixed Angle Torque Defining Screw Kit

Reason for recall

Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.

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