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.
Reported: July 2, 2014 Initiated: May 15, 2014 #Z-1925-2014
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.
Reason for Recall
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 1
- Distribution
- US Nationwide Distribution in the state of California
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 1.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1925-2014.
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