Recalls / —

—#175840

Product

XP-XP Tibial Tray - Interlok 73 mm Item # 195756

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 562200 664340 613420 512640 820800 820820 650460 422530 820780 677550 589910 664350 664360 664370 677540 677560 972780 758360 758340 972800 089920 101940 158830 273080 158830R 101950 158840 207050 101960 036290 036300 322490 998100 282810 322510 358980 434000 434000R 282840 434050 101970 207040 358990 468160 499260 505110 468170 505120 499270 499270R 558560 558540 273050 505100 558550 282880 207030 434010 499280 864730 885110 592460 916870 791000 916880 592480 828730 885100 434040 592470 505090 840740 061430 061440 499290 975620 093410 958450 011480 103050 159320 223170 261100 293920 293890 293910 297080 131240 181450 181460 201960 241470 855400 337030 336160 371610 384240 998090 371600 116050 432340 592450 023390 336150 384260 511480 418740 599840 556590 634270 467220 664210 716110 684960 705680 715890 587340 920610 985960 882110 906750 906740 985980 029280 072950 072970 126030 126040 163020 221420 396410 163030 247370 247380 293140 293150 318560 318570 336740 374510 374520 390120 441990 336730 390100 441970 441980 478970 478950 509820 533610 450450 509790 576180 625640 639690 543380 593640 543390 625610 481890 576190 670610 708700 741550 741560 559040 560370 808330 183530 306440 808320 570290 850970 873570 833210 850960 873560 758550 780250 758560 780240 999370 943550 950990 018170 917650 999350 999480 522680 570280 137520 219830 111720 191180 076710 076720

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 #175840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.