Z-0414-2018Class II

Equinoxe Cage, Glenoid, Alpha, Small

Name: Z-0414-2018 Equinoxe Cage, Glenoid, Alpha, Small
Creator: Exactech, Inc.
Published: 2017-08-31
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-08-31 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative... on 2017-08-31. FDA classified it as Class II and gives the reason as "Potentially mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0414-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Posted: 2018-01-18
Terminated: 2019-08-06
Recalling firm: Exactech, Inc.
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.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Potentially mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Consignees were sent a Recall Notice dated 8/31/2017 by mail informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions please call (800) 392-2832.
Quantity in commerce: 30
Distribution: Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
Product codes and lots: Catalog #: 314-13-03 Serial Range: 5013050 - 5013079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0414-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0414-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-26
Z-0415-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-26

Product code KWS

K113309Class IIExactech Equinoxe Cage GlenoidsExactech, Inc. / cleared 2011-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)