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XP-XP Tibial Tray - Interlok 69 mm Item # 195754

FDA Device Recall #Z-2523-2019 — Class II — August 15, 2019

Recall Summary

Recall Number Z-2523-2019
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
Quantity 1282 units

Product Description

XP-XP Tibial Tray - Interlok 69 mm Item # 195754

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 590860 660490 590850 560350 562180 650420 758270 841570 650430 613370 303400 589890 972740 998060 998040 972730 043990 066130 101900 174980 282760 101920 174970 207000 258020 101920R 066140 101890 101930 258030 036260 322420 374530 374550 358950 358950R 036250 358940 207020 336660 207010 420360 336960 558600 558610 592310 374520 420400 592340 282770 592330 499140 499130 499130R 381700 381710 499110 322400 381720 802050 855300 802050R 802060 840700 864710 802060R 061380 223100 885070 958400 975590 975600 011450 023370 958410 984760 011440 499120 828710 166070 885060 916840 916840R 840690 558620 061390 115970 131220 115990 159300 181400 093390 181410 201940 103020 293790 223090 297190 293820 592290 418710 336120 418700 336100 418690 420380 467190 599780 511460 556570 634200 664170 705610 684910 587280 684900 297180 716090 705630 716080 715810 715790 882080 715800 715780 985910 985920 029250 906690 906710 029260 920580 072870 072890 125990 126000 162970 396350 432530 162990 221390 247330 293100 247310 247320 293110 318470 336700 318480 318500 336690 882090 389990 390020 374450 441910 478860 374420 441920 441930 478880 478890 509710 509720 543330 522630 543300 576140 576150 593600 593610 639640 639650 625500 625480 670550 450430 758520 708440 741510 570250 670560 758510 780190 833180 708470 741520 808230 808250 850930 780200 850920 873520 917620 943530 950960 873530 076670 076680 999320 183440 481860 522650 559020 570230 999440 999310 018130 999450 202940 303390 111690 219790 137500 111660 191140 512610 422510 590870

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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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