Recall Z-1071-2012 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Biomet, Inc.
Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. Intended for primary and revision joint arthroplasty for use in cemented applications.
| Date | Feb 21, 2012 (initiated Dec 14, 2011) |
| Status | Terminated |
| Reason | A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles. |
| Root cause | Process change control |
| Action | December 14, 2011 Urgent Medical Device Recall Notices were sent to Distributors and hospital OR managers describing the product, problem, risks associated with the recall, and actions to be taken. The notice included Instructions to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, prior to returning product by priority mail to the attention of Angi Dickson, Biomet , 56 East Bell Drive Warsaw, IN, USA 46580 with a copy of the response form. Receipt of the notice should also be confirmed by calling 800-348-9500, extension 3983 or 3009. |
| Quantity | 10 units |
| Distribution | International Only Distribution -- Netherlands & UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051975 | POROUS COATED DISCOVERY ELBOW Biomet, Inc., Sep 6, 2005 |