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XP-XP Tibial Tray - Interlok 71 mm Item # 195755

FDA Device Recall #Z-2522-2019 — Class II — August 15, 2019

Recall Summary

Recall Number Z-2522-2019
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 1221 units

Product Description

XP-XP Tibial Tray - Interlok 71 mm Item # 195755

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 450440 590880 512630 820720 820750 841600 841620 664320 841610 972770 589900 660500 664300 664310 677650 841580 664300R 972750 998070 758320 044000 841590 044020 066160 677640 066150 381750 420270 664330 381750R 381730 433990 374560 282790 374540 420280 433960 381740 358960 758290 468150 505080 036280 998080 089890 358970 374570 499170 505060 358970R 374570R 322450 282800 499150 420250 499160 499180 592370 468140 505070 592380 592350 322460 036270 505050 840730 885090 840710 855340 864720 885080 592360 592400 916860 958440 916850 828720 975610 958430 011470 023380 061400 061410 984770 181440 103040 181420 103030 131230 159310 061420 116010 116030 261080 293870 241450 297200 336140 293850 223150 241440 261090 384230 336980 337000 093400 223130 201950 297070 371590 336130 556580 587300 371560 418730 432380 384220 467200 511470 599810 599810R 634230 664180 684930 705650 715820 716100 715830 715840 715840R 882100 920600 906730 906720 029270 072940 985950 072920 126020 985940 396390 126010 163000 163010 247340 247360 247350 221400 293130 318540 293120 318530 336720 318510 336710 374470 374490 390050 318520 390070 570260 478910 478920 478940 441940 441950 441960 509740 543370 543350 509780 593630 625550 522640 576160 576170 593620 625570 639660 639670 670580 708620 670590 708540 741540 780230 758540 808280 522660 560360 780210 808300 570270 741530 758530 850950 850940 833190 873550 873540 917630 999330 999340 018150 999470 076700 111700 917640 943540 950970 999460 076690 111710 183520 481870 481880 559030 481880R 072650 137510 191160 219820 289240 562190 613400 650440 650450 422520

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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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