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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 NexGen see related information
Date Initiated by Firm February 04, 2015
Date Posted March 26, 2015
Recall Status1 Terminated 3 on July 16, 2015
Recall Number Z-1325-2015
Recall Event ID 70605
510(K)Number K040487  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
Product NexGen 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
Action Zimmer 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 Commerce 1 unit
Distribution US Distribution in the state of CA
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 = MBH and Original Applicant = IMPLEX CORP.
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