DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement pro
FDA device recall Z-1925-2014 · posted 2014-06-26 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JDC
- Quantity affected
- 1
- Distribution
- US Nationwide Distribution in the state of California
- Date initiated
- 2014-05-15
- Date posted
- 2014-06-26
- Date terminated
- 2015-03-16
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISCOVERY ELBOW (K013042) | Biomet Orthopedics, Inc. | 2001-10-10 |