Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usag...

FDA Device Recall #Z-1547-2013 — Class II — April 29, 2013

Recall Summary

Recall Number Z-1547-2013
Classification Class II — Moderate risk
Date Initiated April 29, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 75

Product Description

Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Reason for Recall

Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in su

Distribution Pattern

Worldwide Distribution - USA Nationwide: CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI. and the countries of Netherlands, Costa Rica, Japan, and San Juan.

Lot / Code Information

Catalog number: 14-442021 and lot number:757910

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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.