Recall Z-1071-2012
Biomet, Inc. · initiated December 14, 2011
Product
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.
Codes / lots: REF 114700, Lot 797550
Reason for recall
A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
FDA-determined cause: Process change control
Action taken
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. Questions related to this notice should be directed to 574-371-3983 or 574-371-3009 Monday through Friday 8 AM to 5 PM.
Details
- Recall number
- Z-1071-2012
- Initiated
- December 14, 2011
- Posted by FDA
- February 21, 2012
- Terminated
- December 12, 2012
- Product code
- JDC – Prosthesis, Elbow, Constrained, Cemented
- Quantity
- 10 units
- Distribution
- International Only Distribution -- Netherlands & UK.
- Recalling firm
- Biomet, Inc., Warsaw, IN