Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

FDA Device Recall #Z-0867-2017 — Class II — November 29, 2016

Recall Summary

Recall Number Z-0867-2017
Classification Class II — Moderate risk
Date Initiated November 29, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Synthes (USA) Products LLC
Location West Chester, PA
Product Type Devices
Quantity 31 units

Product Description

Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

Reason for Recall

The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Catalog ID (part # 60.119.012), Lot Number FL00528

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Z-1239-2024 Class II TFNA Femoral Nail 9mm, right, 130¿, L 235mm-In... Jan 24, 2024
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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.