Z-0459-2021Class II

Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

Name: Z-0459-2021 Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Creator: Exactech, Inc.
Published: 2020-10-06
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2020-10-06 / Terminated / root cause: packaging

FDA source

Exactech, Inc. began a recall of Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium on 2020-10-06. FDA classified it as Class II and gives the reason as "The product may be mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0459-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-06
Posted: 2020-11-17
Terminated: 2023-11-13
Recalling firm: Exactech, Inc.
Product: Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: The product may be mislabeled.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Exactech distributed the recall notice to consignees in possession of affected inventory worldwide on 10/06/2020. Consignees have been instructed to: -Immediately cease distribution or use of this product. -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the attached Recall Inventory Response Form to Exactech.
Quantity in commerce: 69 devices
Distribution: US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom
Product codes and lots: Catalog 314-13-23, Serial Numbers: 6262746 6262747 6262748 6262749 6262750 6262751 6262753 6262754 6262756 6262757 6262758 6262759 6262760 6262761 6262762 6262763 6142776 6142777 6142779 6142780 6142782 6142783 6142785 6142787 6142788 6142790 6142792 6142793 6142794 6142795 6142796 6142798 6142801 6142802 6142803 6142804 6130334 6130335 6130336 6130340 6130341 6130343 6130344 6130347 6130352 6130353 6130355 6130356 6130357 6130358 6130361 6130365 6130366 6130367 6130368 6147287 6147294 6147297 6147298 6147299 6147300 6147301 6147303 6147303 6147308 6147310 6147314 6147317 6147318

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0459-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0459-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-17
Z-0460-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)