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Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266...

FDA Device Recall #Z-0302-2020 — Class II — October 10, 2019

Recall Summary

Recall Number Z-0302-2020
Classification Class II — Moderate risk
Date Initiated October 10, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 5,459,583 total devices

Product Description

Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439 32855090448 32855090450 32855090465 32855090484 32855090496 32855090497 32855090498 32855090501 32855090507 32855090512 32855090519 32855090520 32855090531 32855090543 32855090576 32855090585 32855090586 32855090593 32855090598 32855090599 32855090609 32855090615 32855090622 32855090628 32855090636 32855090637 32855090638 32855090640 32855090658 32855090659 32855090661 32855090715 32855090734 32855510763 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510808 32855510822 32855510843 32855510844 32855140373 32855411710 32855430479 32855430480 32855430496 32855430498 32855430519 32855430529 32855430533 32855430535 32855430542 32855430544 32855430582 32855430588 32855450430 32855450439 32855450471 32855450483 32855450525 32855470651 32855470715 32855470793 32855470795 32855470796 32855470866 32855470920 32855470921 32855470923 32855480803 32855480808 32855480823 32855480824 32855480828 32855480829 32855480945 32855480963 32855480990 32855481016 32855910440 32855910454 32855910455 32855910456 32855910475 32855910485 32873400307

Reason for Recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Distribution Pattern

Distributed nationwide.

Lot / Code Information

All product manufactured prior to January 2014.

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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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