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Recall Observatory FDA recall evidence

Device product

HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 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

Z-3263-2018

August 09, 2018

Class II

Product summary

Firm
Biomet UK Ltd.
Event
Event 80921
Status
Terminated
Classification
Class II
Quantity
44 units
Official record key
device-enforcement:Z-3263-2018

Official wording

Reason: 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

Code information: Lot Number: 3222067 3355792 3609499 3609508 3619245 3623355 3623356 3700289 3700610 3829536 3843022 3847671 3847672 3879198 3879199 3879200 3879202 3889526 3897103 3897106 3897115 3902248 3918363 3918364

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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