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XP-XP Tibial Tray - Interlok 75 mm Item # 195757

FDA Device Recall #Z-2520-2019 — Class II — August 15, 2019

Recall Summary

Recall Number Z-2520-2019
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 973 units

Product Description

XP-XP Tibial Tray - Interlok 75 mm Item # 195757

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 664400 664380 677580 562210 758380 650470 677760 677590 677750 758410 664390 664410 677570 613450 972810 972820 998120 158870 677770 677780 998110 283010 273090 273100 677740 703240 592490 592490R 592530 592620 703080 592660 703160 703160R 558590 592640 592650 592640R 558580 703090 703120 282950 505130 505140 703100 703190 703230 703260 703200 158890 283020 558570 592510 592520 592630 677720 703070 703170 703210 791010 592520R 322550 322530 592500 885120 975630 505160 864740 958470 855430 592540 703150 828740 505150 703060 703130 703140 703060R 840750 103060 131250 159330 131250R 011490 061450 093420 181470 703180 023400 116070 201970 036310 336740 241480 223190 261110 297090 371620 371640 384280 418750 432410 634300 599880 556600 664220 467240 511490 715900 715910 587370 684980 716120 920620 882120 906770 029290 906760 986000 072990 986030 396430 126060 163040 163060 247400 247390 705700 126050 293160 318590 293170 374530 336750 336760 374540 390140 442010 390170 442000 318580 478980 479000 479010 509860 509840 576200 543410 576210 625670 639710 625690 543400 450460 741570 780260 758570 780280 522710 559050 221440 670630 741580 708770 593650 481900 833240 873590 183550 808360 873580 850980 850990 808390 708780 076750 999390 560380 570300 570310 111730 076730 917660 951010 076740 943570 018190 137530 999380 191190 219870 289250

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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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