Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with… recallZ-0033-2009 · Biomet, Inc. · initiated May 23, 2008
Terminated All recalls posted in October 2008
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 component in the package is not the correct size.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0033-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 23, 2008
- Posted by the FDA
- Oct 3, 2008
- Recalling firm
- Biomet, Inc.
- Quantity
- 5
- Product code
- JDC
- FDA submissions
- K013042
- Distribution
- USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.
Product description
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.
Code information (models, lots, serial numbers)
Lot 440370.
Other devices under the same FDA submission
12 devices cleared under K013042 — 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 540-53-075Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED11 reports
- DJO SURGICAL 540-63-075Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED9 reports
- DJO SURGICAL 540-64-075Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED9 reports
- DJO SURGICAL 540-53-115Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED7 reports
- DJO SURGICAL 540-55-075Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED5 reports
- DJO SURGICAL 540-54-075Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED4 reports
- DJO SURGICAL 540-63-115Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- DJO SURGICAL 540-54-115Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- 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
- DJO SURGICAL 540-55-115Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- DJO SURGICAL 540-65-115Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 49465).
- Z-0032-2009 · TerminatedBiomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; RE…
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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