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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-2506-2019
Recall Event ID 83594
510(K)Number K132873  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product XP-CR Tibial Tray - Interlok 67mm
Item # 195271
Code Information Lot Number 486100 262400 291180 584260 663550 562250 666830 660450 841520 917700 966720 966720R 075450 075460 075500 663530 995960 322020 043860 090190 206820 075440 745670 352820 383680 075470 745650 513340 159230 258060 429230 161960 161950 161930 161910 161920 162010 161860 274480 161870 161900 274460 996070 274490 274510 721690 322000 456750 456750R 274470 374780 951150 075510 469490 721670 309710 274500 309680 309690 075490 309700 585540 883560 221140 374030 920540 279010 450330 672510 575980 821280 943360 599120 600770 712550 717160 017970 076400 076410 220040 175290 175290R 289160 676270 676300 228610 351290 395400 395420 445370 395400R
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 567 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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