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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 FirmFebruary 04, 2015
Date PostedMarch 26, 2015
Recall Status1 Terminated 3 on July 16, 2015
Recall NumberZ-1325-2015
Recall Event ID 70605
510(K)NumberK040487 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
ProductNexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
Code Information 20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T
Recalling Firm/
Manufacturer		 Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Rd
Parsippany NJ 07054-3722
For Additional Information Contact
973-576-0032
Manufacturer Reason
for Recall		One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
FDA Determined
Cause 2		Error in labeling
ActionZimmer Trabecular Metal Technology sent an email dated 12/10/2014 to their sole customer. The customer was requested to return the affected product.
Quantity in Commerce1 unit
DistributionUS Distribution in the state of CA
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 = MBH
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