Discovery Elbow System Humeral Condyle Set- Hexalobular… recallZ-1071-2012 · Biomet, Inc. · initiated Dec 14, 2011
Terminated All recalls posted in February 2012
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
A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
FDA root cause category: Process change control
What the company is doing
December 14, 2011 Urgent Medical Device Recall Notices were sent to Distributors and hospital OR managers describing the product, problem, risks associated with the recall, and actions to be taken. The notice included Instructions to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, prior to returning product by priority mail to the attention of Angi Dickson, Biomet , 56 East Bell Drive Warsaw, IN, USA 46580 with a copy of the response form. Receipt of the notice should also be confirmed by calling 800-348-9500, extension 3983 or 3009. Questions related to this notice should be directed to 574-371-3983 or 574-371-3009 Monday through Friday 8 AM to 5 PM.
Recall details
- Recall number
- Z-1071-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 14, 2011
- Posted by the FDA
- Feb 21, 2012
- Recalling firm
- Biomet, Inc.
- Quantity
- 10 units
- Product code
- JDC
- FDA submissions
- K051975
- Distribution
- International Only Distribution -- Netherlands & UK.
Product description
Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. Intended for primary and revision joint arthroplasty for use in cemented applications.
Code information (models, lots, serial numbers)
REF 114700, Lot 797550
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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