Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW… recallZ-2660-2011 · Biomet, Inc. · initiated Apr 29, 2011
Terminated All recalls posted in June 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-2660-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 29, 2011
- Posted by the FDA
- Jun 24, 2011
- Recalling firm
- Biomet, Inc.
- Quantity
- 10 KITS
- Product code
- JDC
- FDA submissions
- K051975
- Distribution
- Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.
Product description
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.
Code information (models, lots, serial numbers)
LOT 183300
Other devices under the same FDA submission
2 devices cleared under K051975 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 540-53-155Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- DJO SURGICAL 540-64-155Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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