FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 Metric Blvd., Austin, TX 78758
FDA device recall Z-0418-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The sterility has the potential to be compromised.
- Action taken
- Encore Medical Lp sent a Urgent Field Safety Notice dated August 17, 2011. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately quarantine these devices if you have not already done so. Contact Customer Service to obtain replacement devices as well as an RMA. Return all affected devices by October 31, 2011, using the RMA Customer Service provided in step #3. If you have any further questions you may call (512 ) 834-6330. For International Customer Service please call (512) 834-6275.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 169 units
- Distribution
- Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.
- Date initiated
- 2011-08-17
- Date posted
- 2012-01-11
- Date terminated
- 2012-05-11
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOUNDATION 9MM FORGED CEMENTED STEM (K961890) | Encore Orthopedics, Inc. | 1996-06-14 |