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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Distal Femoral Augment Block

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  Class 2 Device Recall NexGen Distal Femoral Augment Block see related information
Date Initiated by Firm October 31, 2018
Create Date December 18, 2018
Recall Status1 Terminated 3 on April 08, 2019
Recall Number Z-0630-2019
Recall Event ID 81604
510(K)Number K152494  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw
Item Number: 00599003523

NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
Code Information Lot Number: 62925336 UDI Number: (01)00889024224131(17)250228(10)62925336
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Screw is missing from the package
FDA Determined
Cause 2		 Process control
Action Zimmer Biomet issued "URGENT MEDICAL DEVICE RECALL" Letter on 10/31/18 via email and FedEx to the consumer/user level, including any intermediate wholesale or retail consignees, distributors and Risk managers. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals that have previously used the product. Hospital risk managers responsibilities include the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 19 units
Distribution Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.
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 = JWH and Original Applicant = ZIMMER, INC.
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