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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate

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 Class 2 Device Recall Zimmer NaturalKnee II System Modular Cemented Tibial Baseplatesee related information
Date Initiated by FirmMarch 18, 2009
Date PostedJune 30, 2009
Recall Status1 Terminated 3 on October 23, 2009
Recall NumberZ-1482-2009
Recall Event ID 51406
510(K)NumberK023528 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductZimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-002. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.
Code Information All lots.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		The tibial spacer will not affix to the distal surface of the baseplate, as intended.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionZimmer, Inc. issued an "Urgent-Device Recall" letter dated March 18, 2009 instructing users to cease using and return the affected product accompanied with a completed Inventory Return Certification form. The inventory Return Certification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. Further questions should be addressed to Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce834 of all products
DistributionWorldwide Distribution - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland.
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.
510(K) Database510(K)s with Product Code = JWH
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