Z-0460-2021Class II

Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

Name: Z-0460-2021 Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, 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 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, 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-0460-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-06
Posted: 2020-11-17
Terminated: 2023-11-13
Recalling firm: Exactech, Inc.
Product: Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, 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: 40 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 314-13-33, Serial Numbers: 6259572 6259573 6259575 6259577 6259578 6259579 6259583 6259584 6259587 6259588 6259590 6259591 6259592 6259594 6259595 6132993 6132994 6132995 6132996 6132997 6132998 6132999 6133000 6133002 6133003 6133005 6133008 6133009 6133010 6133011 6133013 6133014 6133017 6133020 6133021 6133023 6133029 6133030 6133031 6133032

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0460-2021
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)