Recall Z-2583-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
| Date | Sep 4, 2014 (initiated Jul 10, 2014) |
| Status | Terminated |
| Reason | Zimmer received a trend of complaints indicating corrosion of product. |
| Root cause | Device Design |
| Action | Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer. All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identi |
| Quantity | 8638 distribution events |
| Distribution | Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073286 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM Zimmer, Inc., Mar 7, 2008 |