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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-2525-2019
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 65 mm
Item # 195752
Code Information Lot Number 590800 309530 579280 309460 590810 590820 309510 650390 562160 613330 758190 571150 589750 972670 029010 065310 029010R 206950 043980 065640 174940 043980R 174930 206930 257980 336590 206940 257990 028990 029000 783130 783160 801980 801980R 783100 885030 916820 864690 958350 958350R 783120 783150 855240 958340 840660 801970 023350 783080 036230 975570 984720 984740 011420 103000 159280 093370 061330 115950 131180 181380 297160 309500 511440 599700 467150 634140 664150 684850 664150R 587250 309480 705540 328040 715740 716040 241420 261140 882060 920560 029220 072830 906660 985890 396310 125970 162900 162920 221350 076130 247260 318440 374340 336670 374370 293080 441880 478800 478820 509650 509620 076090 543210 543230 576090 559000 559000R 576100 593570 450410 522600 639610 670520 708400 741480 741470 758490 780170 833160 183380 808180 850890 917600 873480 873490 963440 999290 999290R 943500 560300 570190 570200 018080 076650 137480 111640 191100 579300 219730 289200 261920
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 857 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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