Recalls / —

—#175843

Product

XP-XP Tibial Tray - Interlok 67 mm Item # 195753

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 562170 613350 677700 677680 664240 758250 758230 753770 753780 998030 753790 590830 590840 660470 660480 664230 664260 664270 677660 677670 677710 590830R 677660R 677670R 972690 758210 972710 206980 174950 174950R 174960 206970 258000 258010 664290 664290R 664280 206960 282720 322360 468220 036240 219760 336620 359230 358920 592270 336640 592260 592260R 592230 592240 592250 592220 282740 322380 468230 358930 864700 802030 885040 802030R 802020 828700 828700R 975580 958380 840680 855270 011430 023360 061360 592200 916830 131190 093380 201930 223080 241430 103010 181390 159290 984750 297170 115960 261150 293750 958370 261160 336090 418680 432510 061340 587260 511450 599740 705580 634170 705560 664160 684880 715770 715750 716070 715760 716050 882070 985900 029240 906680 920570 029230 125980 396320 221370 072850 162930 162950 247270 247300 293090 318450 318460 336680 374390 374410 389960 441900 478840 478850 441890 298480 467170 509670 543250 543280 509690 576120 576110 593580 625460 639630 670540 708420 570220 741490 758500 570210 741500 780180 450420 522610 450420R 808210 833170 850900 850910 873500 873510 943520 999300 917610 950930 999430 183390 559010 560320 018100 111650 076660 191120 137490 422500 512600 650400 650410 571160 589780

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 #175843. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.