FDA recall Z-3262-2018

Product

HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 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

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

Key facts

Status

Terminated

Initiation date

2018-08-09

Report date

2018-10-03

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgend, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3262-2018