FDAFDA · Food and drugs·Recall number Z-1925-2014
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.
Published July 2, 2014 · Recall initiated: May 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- US Nationwide Distribution in the state of California
- Lot
- Catalog/REF #: 114905, Lot #: M846640
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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