FDA-Device2014-07-02Class II
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.
Biomet, Inc.
Hazard
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.
Sold states
US Nationwide Distribution in the state of California
Affected count
1
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2014Don't want to check this manually?
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