Date Initiated by Firm |
October 10, 2006 |
Date Posted |
March 28, 2007 |
Recall Status1 |
Terminated 3 on December 04, 2007 |
Recall Number |
Z-0651-2007 |
Recall Event ID |
37069 |
Product Classification |
knee prosthesis surgical instrument - Product Code JWH
|
Product |
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272522. |
Code Information |
Lot 97000418. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
574-267-6131
|
Manufacturer Reason for Recall |
The device was cut to an incorrect angle, which may result in an incorrect bone cut.
|
FDA Determined Cause 2 |
Other |
Action |
Product was removed from customer location during visit on 10/10/2006. |
Quantity in Commerce |
1 |
Distribution |
One medical facility in Michigan. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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