HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Numb...

FDA Device Recall #Z-3264-2018 — Class II — August 9, 2018

Recall Summary

Recall Number Z-3264-2018
Classification Class II — Moderate risk
Date Initiated August 9, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomet UK Ltd.
Location Bridgend
Product Type Devices
Quantity 6 units

Product Description

HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

Reason for Recall

HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

Distribution Pattern

US Nationwide in the states of AZ, MO, NJ and NM

Lot / Code Information

Lot Number 3170094 3369699 3622113 3664778 3680647

Other Recalls from Biomet UK Ltd.

Recall # Classification Product Date
Z-3262-2018 Class II HipLOC Hip Fracture Fixation System-Hiploc Syst... Aug 9, 2018
Z-3261-2018 Class II HipLOC Hip Fracture Fixation System- Hiploc Sys... Aug 9, 2018
Z-3263-2018 Class II HipLOC Hip Fracture Fixation System-Hiploc Syst... Aug 9, 2018

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.