Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Templa
FDA device recall Z-0349-2012 · posted 2011-12-02 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The strike plate may dislodge from the broach stem handle during impaction of the device.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 30 units
- Distribution
- Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy
- Date initiated
- 2011-10-26
- Date posted
- 2011-12-02
- Date terminated
- 2012-09-05
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOUNDATION KNEE SYSTEM TIBIAL COMPONENT (K970031) | Encore Orthopedics, Inc. | 1997-04-02 |