Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treat...

FDA Device Recall #Z-2207-2021 — Class II — May 12, 2021

Recall Summary

Recall Number Z-2207-2021
Classification Class II — Moderate risk
Date Initiated May 12, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Medical Division of Stryker Corporation
Location Portage, MI
Product Type Devices
Quantity 3 units

Product Description

Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X

Reason for Recall

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.

Lot / Code Information

UDI (DI#) 07613327278149 07613327278149 07613327278194

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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.