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Biomet, Inc. recalls DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow
Recalled July 2, 2014 · FDA recall Z-1925-2014 · Biomet
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. · FDA Class II
Units
1
Sold at
US Nationwide Distribution in the state of California
Description
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.
Product
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.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →