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XP-XP Tibial Tray - Interlok 67 mm Item # 195753

FDA Device Recall #Z-2524-2019 — Class II — August 15, 2019

Recall Summary

Recall Number Z-2524-2019
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 1210 units

Product Description

XP-XP Tibial Tray - Interlok 67 mm Item # 195753

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 562170 613350 677700 677680 664240 758250 758230 753770 753780 998030 753790 590830 590840 660470 660480 664230 664260 664270 677660 677670 677710 590830R 677660R 677670R 972690 758210 972710 206980 174950 174950R 174960 206970 258000 258010 664290 664290R 664280 206960 282720 322360 468220 036240 219760 336620 359230 358920 592270 336640 592260 592260R 592230 592240 592250 592220 282740 322380 468230 358930 864700 802030 885040 802030R 802020 828700 828700R 975580 958380 840680 855270 011430 023360 061360 592200 916830 131190 093380 201930 223080 241430 103010 181390 159290 984750 297170 115960 261150 293750 958370 261160 336090 418680 432510 061340 587260 511450 599740 705580 634170 705560 664160 684880 715770 715750 716070 715760 716050 882070 985900 029240 906680 920570 029230 125980 396320 221370 072850 162930 162950 247270 247300 293090 318450 318460 336680 374390 374410 389960 441900 478840 478850 441890 298480 467170 509670 543250 543280 509690 576120 576110 593580 625460 639630 670540 708420 570220 741490 758500 570210 741500 780180 450420 522610 450420R 808210 833170 850900 850910 873500 873510 943520 999300 917610 950930 999430 183390 559010 560320 018100 111650 076660 191120 137490 422500 512600 650400 650410 571160 589780

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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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