Z-0033-2009

Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE...

Name: Z-0033-2009 Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE...
Creator: Biomet, Inc.
Published: 2008-05-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-05-23 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet... on 2008-05-23. The reason FDA records is "The component in the package is not the correct size". 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-0033-2009
Status: Terminated
Initiated: 2008-05-23
Posted: 2008-10-03
Terminated: 2009-09-22
Recalling firm: Zimmer GmbH
Product: Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: The component in the package is not the correct size.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance.
Quantity in commerce: 5
Distribution: USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.
Product codes and lots: Lot 440370.

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