Recall Z-0198-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or pri
| Date | Nov 8, 2014 (initiated Oct 9, 2014) |
| Status | Terminated |
| Reason | Cleaning process validation failure. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer sent an Urgent Medical Device Recall letter dated October 9, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer sales representative with the quarantine of any affected product. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2 |
| Quantity | 138 units |
| Distribution | US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113369 | ZIMMER PERSONA KNEE SYSTEM Zimmer, Inc., Mar 27, 2012 |