DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL… recallZ-1925-2014 · Biomet, Inc. · initiated May 15, 2014
Class II Terminated All recalls posted in June 2014
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
Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Biomet sent an Urgent Medical Device Recall Notice letter dated May 28, 2014 to their customer. The letter identified the affected product, problem and actions to be taken. The letter instructed physician to monitor the patient for any pain that may require surgical intervention. For questions call (574) 372-1570.
Recall details
- Recall number
- Z-1925-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 15, 2014
- Posted by the FDA
- Jun 26, 2014
- Recalling firm
- Biomet, Inc.
- Quantity
- 1
- Product code
- JDC
- FDA submissions
- K013042
- Distribution
- US Nationwide Distribution in the state of California
Product description
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Code information (models, lots, serial numbers)
Catalog/REF #: 114905, Lot #: M846640
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
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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