FDA-Device2018-10-03Class II

HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 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

Biomet UK Ltd.
Hazard

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

Sold states
US Nationwide in the states of AZ, MO, NJ and NM
Affected count
1 unit
Manufactured in
Waterton Industrial Estate, Bridgend, United Kingdom
Products
HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3261-2018

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