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XP-XP Tibial Tray - Interlok 73 mm Item # 195756

FDA Device Recall #Z-2521-2019 — Class II — August 15, 2019

Recall Summary

Recall Number Z-2521-2019
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 906 units

Product Description

XP-XP Tibial Tray - Interlok 73 mm Item # 195756

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 562200 664340 613420 512640 820800 820820 650460 422530 820780 677550 589910 664350 664360 664370 677540 677560 972780 758360 758340 972800 089920 101940 158830 273080 158830R 101950 158840 207050 101960 036290 036300 322490 998100 282810 322510 358980 434000 434000R 282840 434050 101970 207040 358990 468160 499260 505110 468170 505120 499270 499270R 558560 558540 273050 505100 558550 282880 207030 434010 499280 864730 885110 592460 916870 791000 916880 592480 828730 885100 434040 592470 505090 840740 061430 061440 499290 975620 093410 958450 011480 103050 159320 223170 261100 293920 293890 293910 297080 131240 181450 181460 201960 241470 855400 337030 336160 371610 384240 998090 371600 116050 432340 592450 023390 336150 384260 511480 418740 599840 556590 634270 467220 664210 716110 684960 705680 715890 587340 920610 985960 882110 906750 906740 985980 029280 072950 072970 126030 126040 163020 221420 396410 163030 247370 247380 293140 293150 318560 318570 336740 374510 374520 390120 441990 336730 390100 441970 441980 478970 478950 509820 533610 450450 509790 576180 625640 639690 543380 593640 543390 625610 481890 576190 670610 708700 741550 741560 559040 560370 808330 183530 306440 808320 570290 850970 873570 833210 850960 873560 758550 780250 758560 780240 999370 943550 950990 018170 917650 999350 999480 522680 570280 137520 219830 111720 191180 076710 076720

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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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