Recall Z-0414-2018— Exactech, Inc.

Name: FDA recall Z-0414-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-31

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2017-08-31, terminated 2019-08-06. It names one FDA 510(k) clearance: K113309. Product: Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.. Reason: Potentially mislabeled..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Terminated: 2019-08-06
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K113309 — EXACTECH EQUINOXE CAGE GLENOIDSExactech, Inc.·cleared 2011-12-08

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 Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Reason for recall

Potentially mislabeled.

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