Recalls / —

—#175838

Product

XP-XP Tibial Tray - Interlok 79 mm Item # 195758

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K132873

Affected lot / code info

Lot Number 664420 664430 677600 677610 219880 841630 158920 158940 758430 758450 102010 972850 998140 089940 998150 101990 101980 273110 972840 036320 283060 322560 273120 273120R 322570 592590 592600 592550 703470 703530 703480 703540 703580 592560 703450 703490 703510 703570 703590 703500 703520 592610 703550 283040 592580 703460 790990 102000 592570 703600 791020 828750 703610 966270 061470 093430 703620 975640 011500 023410 061460 093440 703560 855460 864750 131260 116090 103070 241490 181480 201980 223200 159340 885130 336760 090000 297100 371660 467260 418760 371670 432440 556610 261120 585790 384310 511500 587390 634320 530660 384300 664230 685000 715980 882150 715960 906780 906800 920630 715970 126070 126080 073010 029300 396490 986060 163050 986090 221460 247420 163070 247410 293180 293190 318620 374550 374560 318600 442030 390200 390220 442020 478600 509910 543420 576220 576230 450470 479020 509880 543430 593660 625720 625740 639730 670640 560390 708800 741590 741600 708810 183560 481920 481930 481940 780270 851000 481910 559060 758580 780290 999410 808410 833270 873610 917670 943590 999400 111760 076760 018260 076770 851010 137540 111740 018220 261930 191200 261950 289270

Why it was recalled

The locking bar not fully engaging

Root cause (FDA determination)

Manufacturing material removal

Action the firm took

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-

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

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

Timeline

Recall initiated

2019-08-15

Terminated

2021-04-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.