Z-1459-2015Class II

Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component

Name: Z-1459-2015 Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component
Creator: Exactech, Inc.
Published: 2015-02-13
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2015-02-13 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component on 2015-02-13. FDA classified it as Class II and gives the reason as "Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device". 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-1459-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-13
Posted: 2015-04-20
Terminated: 2016-09-29
Recalling firm: Exactech, Inc.
Product: Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Exactech Agents sent a Product Recall Advisory Notice dated February 12, 2015 by mailed to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Recall Inventory Respponse form and return it to Exactech, per the instructions provided on the notice.
Quantity in commerce: 112 devices
Distribution: Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
Product codes and lots: Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1459-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1459-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-20

Product code KWS

K042021Class IIExactech Equinoxe Shoulder SystemExactech, Inc. / cleared 2004-10-26

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)