|
Class 2 Device Recall NextGen Knee |
 |
Date Initiated by Firm |
January 27, 2010 |
Date Posted |
March 02, 2010 |
Recall Status1 |
Terminated 3 on October 17, 2010 |
Recall Number |
Z-0915-2010 |
Recall Event ID |
54359 |
510(K)Number |
k060370
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN. |
Code Information |
lot 61369812. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
Dale Miller 574-267-6131
|
Manufacturer Reason for Recall |
The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions. |
Quantity in Commerce |
14 units |
Distribution |
US and Korea. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
|
|
|
|