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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 XPsee related information
Date Initiated by FirmAugust 15, 2019
Create DateSeptember 12, 2019
Recall Status1 Terminated 3 on April 16, 2021
Recall NumberZ-2518-2019
Recall Event ID 83594
510(K)NumberK132873 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductXP-XP Tibial Tray - Interlok 83 mm Item # 195759
Code Information Lot Number 559070 527660 677630 191210 219890 677620 758460 089950 283100 358850 283080 374620 321750 321770 358830 374580 374590 420310 420320 434060 358860 381760 321690 358840 468200 381770 381780 381780R 321710 434070 420290 468210 023420 011510 864760 093450 093460 885140 855480 975650 828760 061480 331670 103080 131270 159350 116110 223220 116110R 587400 181490 418770 634280 664240 783170 716000 906810 685020 882160 882170 881950 715990 986210 396500 986200 906820 029310 126100 163080 247440 293200 293210 163090 126090 920640 920640R 481960 073030 374570 442040 442050 318630 479060 509960 509930 450480 183670 479050 576240 543440 543450 625770 593670 639750 670660 758590 741610 481970 943600 808440 917680 951040 780300 833290 851020 873620 481950 018270 999420 076780
FEI Number 1825034
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		The locking bar not fully engaging
FDA Determined
Cause 2		Manufacturing material removal
ActionRisk 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 Commerce384 units
DistributionState 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 CycleTPLC 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) Database510(K)s with Product Code = JWH
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