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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen

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 Class 2 Device Recall NexGensee related information
Date Initiated by FirmOctober 10, 2006
Date PostedMarch 28, 2007
Recall Status1 Terminated 3 on December 04, 2007
Recall NumberZ-0647-2007
Recall Event ID 37069
Product Classification knee prosthesis surgical instrument - Product Code JWH
ProductNexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272518.
Code Information Lot 97000414.
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
ActionProduct was removed from customer location during visit on 10/10/2006.
Quantity in Commerce1
DistributionOne medical facility in Michigan.
Total Product Life CycleTPLC 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.
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