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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard XP

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  Class 2 Device Recall Vanguard XP see related information
Date Initiated by Firm August 15, 2019
Create Date September 12, 2019
Recall Status1 Terminated 3 on April 16, 2021
Recall Number Z-2519-2019
Recall Event ID 83594
510(K)Number K132873  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product XP-XP Tibial Tray - Interlok 79 mm
Item # 195758
Code Information Lot Number 664420 664430 677600 677610 219880 841630 158920 158940 758430 758450 102010 972850 998140 089940 998150 101990 101980 273110 972840 036320 283060 322560 273120 273120R 322570 592590 592600 592550 703470 703530 703480 703540 703580 592560 703450 703490 703510 703570 703590 703500 703520 592610 703550 283040 592580 703460 790990 102000 592570 703600 791020 828750 703610 966270 061470 093430 703620 975640 011500 023410 061460 093440 703560 855460 864750 131260 116090 103070 241490 181480 201980 223200 159340 885130 336760 090000 297100 371660 467260 418760 371670 432440 556610 261120 585790 384310 511500 587390 634320 530660 384300 664230 685000 715980 882150 715960 906780 906800 920630 715970 126070 126080 073010 029300 396490 986060 163050 986090 221460 247420 163070 247410 293180 293190 318620 374550 374560 318600 442030 390200 390220 442020 478600 509910 543420 576220 576230 450470 479020 509880 543430 593660 625720 625740 639730 670640 560390 708800 741590 741600 708810 183560 481920 481930 481940 780270 851000 481910 559060 758580 780290 999410 808410 833270 873610 917670 943590 999400 111760 076760 018260 076770 851010 137540 111740 018220 261930 191200 261950 289270
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 The locking bar not fully engaging
FDA Determined
Cause 2		 Manufacturing material removal
Action Risk Manager Responsibilities: 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 will 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. Surgeon Responsibilities: 1.Review this notification for awareness of the contents. 2.There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3.A visual and audible confirmation should be made to ensure complete locking bar insertion. 4.Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 5.Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 6.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-
Distribution State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA JAPAN EMEA SWEDEN ITALY
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, INC.
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