Recalls / —

—#175839

Product

XP-XP Tibial Tray - Interlok 75 mm Item # 195757

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 664400 664380 677580 562210 758380 650470 677760 677590 677750 758410 664390 664410 677570 613450 972810 972820 998120 158870 677770 677780 998110 283010 273090 273100 677740 703240 592490 592490R 592530 592620 703080 592660 703160 703160R 558590 592640 592650 592640R 558580 703090 703120 282950 505130 505140 703100 703190 703230 703260 703200 158890 283020 558570 592510 592520 592630 677720 703070 703170 703210 791010 592520R 322550 322530 592500 885120 975630 505160 864740 958470 855430 592540 703150 828740 505150 703060 703130 703140 703060R 840750 103060 131250 159330 131250R 011490 061450 093420 181470 703180 023400 116070 201970 036310 336740 241480 223190 261110 297090 371620 371640 384280 418750 432410 634300 599880 556600 664220 467240 511490 715900 715910 587370 684980 716120 920620 882120 906770 029290 906760 986000 072990 986030 396430 126060 163040 163060 247400 247390 705700 126050 293160 318590 293170 374530 336750 336760 374540 390140 442010 390170 442000 318580 478980 479000 479010 509860 509840 576200 543410 576210 625670 639710 625690 543400 450460 741570 780260 758570 780280 522710 559050 221440 670630 741580 708770 593650 481900 833240 873590 183550 808360 873580 850980 850990 808390 708780 076750 999390 560380 570300 570310 111730 076730 917660 951010 076740 943570 018190 137530 999380 191190 219870 289250

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 #175839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.