Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 01...

FDA Device Recall #Z-0320-2020 — Class II — October 10, 2019

Recall Summary

Recall Number Z-0320-2020
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

Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 0100551206 0100551207 0100551208 0100551209 0100551210 0100551211 0100551212 0100551213 0100551214 0100551301 0100551302 0100551303 0100551304 0100551305 0100551306 0100551307 0100551308 0100551309 0100551310 0100551311 0100551312 0100551313 0100551314 0100551401 0100551402 0100551403 0100551404 0100551405 0100551406 0100551407 0100551408 0100551409 0100551410 0100551411 0100551412 0100551413 0100551414

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.

Other Recalls from Zimmer Biomet, Inc.

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Z-0696-2021 Class II Spinal Rod Cutter, Item number 00392500200. The... Nov 20, 2020
Z-0570-2021 Class II Polaris 5.5 Spinal System and Polaris 5.5/Cyphe... Nov 17, 2020
Z-0372-2021 Class II ZCA All Poly Acetabular Cup Longevity Crosslink... Sep 24, 2020
Z-0345-2021 Class II ZCA All Poly Acetabular Cup Longevity Crosslink... Sep 24, 2020
Z-0347-2021 Class II ZCA All Poly Acetabular Cup Longevity Crosslink... Sep 24, 2020

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.