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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-2523-2019
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 69 mm
Item # 195754
Code Information Lot Number 590860 660490 590850 560350 562180 650420 758270 841570 650430 613370 303400 589890 972740 998060 998040 972730 043990 066130 101900 174980 282760 101920 174970 207000 258020 101920R 066140 101890 101930 258030 036260 322420 374530 374550 358950 358950R 036250 358940 207020 336660 207010 420360 336960 558600 558610 592310 374520 420400 592340 282770 592330 499140 499130 499130R 381700 381710 499110 322400 381720 802050 855300 802050R 802060 840700 864710 802060R 061380 223100 885070 958400 975590 975600 011450 023370 958410 984760 011440 499120 828710 166070 885060 916840 916840R 840690 558620 061390 115970 131220 115990 159300 181400 093390 181410 201940 103020 293790 223090 297190 293820 592290 418710 336120 418700 336100 418690 420380 467190 599780 511460 556570 634200 664170 705610 684910 587280 684900 297180 716090 705630 716080 715810 715790 882080 715800 715780 985910 985920 029250 906690 906710 029260 920580 072870 072890 125990 126000 162970 396350 432530 162990 221390 247330 293100 247310 247320 293110 318470 336700 318480 318500 336690 882090 389990 390020 374450 441910 478860 374420 441920 441930 478880 478890 509710 509720 543330 522630 543300 576140 576150 593600 593610 639640 639650 625500 625480 670550 450430 758520 708440 741510 570250 670560 758510 780190 833180 708470 741520 808230 808250 850930 780200 850920 873520 917620 943530 950960 873530 076670 076680 999320 183440 481860 522650 559020 570230 999440 999310 018130 999450 202940 303390 111690 219790 137500 111660 191140 512610 422510 590870 
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-
Quantity in Commerce 1282 units
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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