Recall Z-3019-2020— Exactech, Inc.

Name: FDA recall Z-3019-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-24

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2020-08-24, terminated 2023-05-01. It names one FDA 510(k) clearance: K063569. Product: Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.. Reason: Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-24
Terminated: 2023-05-01
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 Compression Screw/Locking Cap Kit 4.5 x 18 mm.

Reason for recall

Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.

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