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various polyethylene implants Custom parts Product Usage: Custom

FDA Device Recall #Z-1862-2017 — Class II — February 17, 2017

Recall Summary

Recall Number Z-1862-2017
Classification Class II — Moderate risk
Date Initiated February 17, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 28,253 in total

Product Description

various polyethylene implants Custom parts Product Usage: Custom

Reason for Recall

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Distribution Pattern

Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK

Lot / Code Information

Items and lots: Item 110010452 732130 920720 Item 110010454 136510 Item 110010455 752320 896040 Item 110010456 383320 879930 Item 110010459 854290 879950 905350 Item 110010462 752460 778490 Item 110010468 827730 Item 110010476 827530 827540 Item 110010716 753050 ItemCP753453 655990 ItemCP753455 656110 ItemCP753461 382210 Item CP753470 436530 Item CP753476 502920 Item CP753478 524950 Item CP753480 436460 Item CP753486 655300 Item CP753488 655470 Item CP753494 467390 Item CP753496 467420 Item CP753502 448730 Item CP753504 453990 Item CP753506 454640 Item CP753508 502970 Item CP753510 831310 Item CP753512 654720 Item CP753514 594570 Item CP753517 594630 Item CP753519 534820 Item CP753521 535090 Item CP753523 654190 Item CP753525 674160 Item CP753531 691490 Item CP753533 691560 Item CP753535 691640 Item CP753537 691680 Item CP753547 691720 Item CP753549 696620

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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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