Biomet UK Ltd. recalls HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Produ…

Recall date

August 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3261-2018

FDA classification

Class II

Brand / firm

Biomet UK Ltd.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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