Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013
This recall has been terminated (originally issued December 2, 2011).
- Recall Initiated
- October 26, 2011
- Posted
- December 2, 2011
- Terminated
- September 5, 2012
- Recall Number
- Z-0349-2012
- Quantity
- 30 units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The strike plate may dislodge from the broach stem handle during impaction of the device.
Distribution
Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy
Lot / Code Info
Lot#'s 35149L02, 36204L06, 37990L06, 38272L13, and 50479L12
Root Cause
Nonconforming Material/Component
Action Taken
DJO Global sent an URGENT FIELD SAFETY NOTICE letter dated October 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information to all those who need to be aware within their organization or to any organization where the affected devices have been transferred. Customers should contact Customer Service to place a replacement order and receive an RMA number and return all affected devices using the RMA number. For any questions call (512) 834-6255.