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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard Knee System

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  Class 2 Device Recall Vanguard Knee System see related information
Date Initiated by Firm May 11, 2018
Date Posted June 01, 2018
Recall Status1 Terminated 3 on November 21, 2019
Recall Number Z-2183-2018
Recall Event ID 80172
510(K)Number K113550  K171054  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard Knee System PS Tibial Bearing, Part Number 183621

Intended for use in knee joint replacement procedures.
Code Information UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150;  UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480;  UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730;  UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370;  UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750;  UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970;  UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680;  UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370;  UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470;  UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060;  UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330;  UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220;  UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080;  UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-371-3071
Manufacturer Reason
for Recall		 The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall (Removal)" letters dated 5/11/2018 to customers on 5/11/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet. a. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returning product box(es) clearly with RECALL. 5. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts in accordance with local regulations. 6. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center 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 voice mail 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 169
Distribution Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.
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 = BIOMET MANUFACTURING CORP.
510(K)s with Product Code = JWH and Original Applicant = Biomet, Inc
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