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

FDA Device Recall #Z-2519-2019 — Class II — August 15, 2019

Recall Summary

Recall Number Z-2519-2019
Classification Class II — Moderate risk
Date Initiated August 15, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Biomet, Inc.
Location Warsaw, IN
Product Type Devices

Product Description

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

Reason for Recall

The locking bar not fully engaging

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

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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