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Class 2 Device Recall NexGen |
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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
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Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
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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.
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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
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For Additional Information Contact |
973-576-0032
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Manufacturer Reason for Recall |
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
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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
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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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510(K) Database |
510(K)s with Product Code = MBH and Original Applicant = IMPLEX CORP.
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