Z-0075-2015Class II

Discovery Elbow Humeral Trial

Name: Z-0075-2015 Discovery Elbow Humeral Trial
Creator: Biomet, Inc.
Published: 2014-09-24
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-09-24 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint... on 2014-09-24. FDA classified it as Class II and gives the reason as "An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0075-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Posted: 2014-10-16
Terminated: 2015-07-14
Recalling firm: Zimmer GmbH
Product: Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components.
Product code: HWT Template
Reason for recall: An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letters dated September 24, 2014, via FedEx overnight to affected customers. The notification included a description of the reason for recall, instructions for responding to the formal recall notification, and affected product, actions to be taken. For questions call (574) 372-1570.
Quantity in commerce: 6
Distribution: Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
Product codes and lots: Catalog Number: 414837 Lot Number: 555011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0075-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0075-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)