Recall Z-0418-2012 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Encore Medical, Lp
FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 Metric Blvd., Austin, TX 78758 The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascula
| Date | Jan 11, 2012 (initiated Aug 17, 2011) |
| Status | Terminated |
| Reason | The sterility has the potential to be compromised. |
| Root cause | Packaging |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961890 | FOUNDATION 9MM FORGED CEMENTED STEM Encore Orthopedics, Inc., Jun 14, 1996 |