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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-2522-2019
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 71 mm
Item # 195755
Code Information Lot Number 450440 590880 512630 820720 820750 841600 841620 664320 841610 972770 589900 660500 664300 664310 677650 841580 664300R 972750 998070 758320 044000 841590 044020 066160 677640 066150 381750 420270 664330 381750R 381730 433990 374560 282790 374540 420280 433960 381740 358960 758290 468150 505080 036280 998080 089890 358970 374570 499170 505060 358970R 374570R 322450 282800 499150 420250 499160 499180 592370 468140 505070 592380 592350 322460 036270 505050 840730 885090 840710 855340 864720 885080 592360 592400 916860 958440 916850 828720 975610 958430 011470 023380 061400 061410 984770 181440 103040 181420 103030 131230 159310 061420 116010 116030 261080 293870 241450 297200 336140 293850 223150 241440 261090 384230 336980 337000 093400 223130 201950 297070 371590 336130 556580 587300 371560 418730 432380 384220 467200 511470 599810 599810R 634230 664180 684930 705650 715820 716100 715830 715840 715840R 882100 920600 906730 906720 029270 072940 985950 072920 126020 985940 396390 126010 163000 163010 247340 247360 247350 221400 293130 318540 293120 318530 336720 318510 336710 374470 374490 390050 318520 390070 570260 478910 478920 478940 441940 441950 441960 509740 543370 543350 509780 593630 625550 522640 576160 576170 593620 625570 639660 639670 670580 708620 670590 708540 741540 780230 758540 808280 522660 560360 780210 808300 570270 741530 758530 850950 850940 833190 873550 873540 917630 999330 999340 018150 999470 076700 111700 917640 943540 950970 999460 076690 111710 183520 481870 481880 559030 481880R 072650 137510 191160 219820 289240 562190 613400 650440 650450 422520
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 1221 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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