Z-1925-2014Class II

DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint...

Name: Z-1925-2014 DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint...
Creator: Biomet, Inc.
Published: 2014-05-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-05-15 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and... on 2014-05-15. FDA classified it as Class II and gives the reason as "Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention". 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-1925-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-06-26
Terminated: 2015-03-16
Recalling firm: Zimmer GmbH
Product: DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet sent an Urgent Medical Device Recall Notice letter dated May 28, 2014 to their customer. The letter identified the affected product, problem and actions to be taken. The letter instructed physician to monitor the patient for any pain that may require surgical intervention. For questions call (574) 372-1570.
Quantity in commerce: 1
Distribution: US Nationwide Distribution in the state of California
Product codes and lots: Catalog/REF #: 114905, Lot #: M846640

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1925-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-26

Product code JDC

K013042Class IIDiscovery ElbowBiomet Orthopedics, Inc. / cleared 2001-10-10

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)