Recall Z-1925-2014 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Biomet, Inc.
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.
| Date | Jun 26, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1 |
| Distribution | US Nationwide Distribution in the state of California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013042 | DISCOVERY ELBOW Biomet Orthopedics, Inc., Oct 10, 2001 |