Z-2660-2011

Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO...

Name: Z-2660-2011 Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO...
Creator: Biomet, Inc.
Published: 2011-04-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-04-29 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY... on 2011-04-29. The reason FDA records is "The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle". 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-2660-2011
Status: Terminated
Initiated: 2011-04-29
Posted: 2011-06-24
Terminated: 2011-08-29
Recalling firm: Zimmer GmbH
Product: Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2011 to all affected customers. The notice describes the product, problem, and actions to be taken by the customers. The notice instructed customers to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Additionally, customers were instructed to ship the package priority mail with a copy of the response form. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday 8 AM to 5 PM.
Quantity in commerce: 10 KITS
Distribution: Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.
Product codes and lots: LOT 183300

Product code JDC

K051975Class IIPorous Coated Discovery ElbowBiomet, Inc. / cleared 2005-09-06

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)