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U.S. Department of Health and Human Services

Class 2 Device Recall NexGenTrabecular Metal Tibial Half Block Augment

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 Class 2 Device Recall NexGenTrabecular Metal Tibial Half Block Augmentsee related information
Date Initiated by FirmFebruary 01, 2019
Create DateMarch 11, 2019
Recall Status1 Terminated 3 on May 15, 2020
Recall NumberZ-1006-2019
Recall Event ID 82125
510(K)NumberK024161 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductNexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.
Code Information Lot Numbers:  63244259 63247617 63279968 61581585T (01) 00889024307902 (17) 210131 (10) 63244259 (01) 00889024307902 (17) 210228 (10) 63247617 (01) 00889024307902 (17) 210228 (10) 63279968 (01) 00889024307902 (17) 210228 (10) 61581585T  
Recalling Firm/
Manufacturer		 Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Rd
Parsippany NJ 07054-3722
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		Potentially comingled, resulting in the product in the box potentially not matching the product on the label
FDA Determined
Cause 2		Mixed-up of materials/components
ActionZimmer Biomet notified sent an Urgent Medical Device Recall on February 1, 2019 via email and Fed'X letter to Distributors, hospitals and surgeons, The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately locate and quarantine affected product in your inventory, complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com. For questions contact Customer Service at 574-371-3071.
Quantity in Commerce26 units
DistributionWorldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS
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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