FDA Recall Terminated

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

Recall: Z-3264-2018 · Initiated August 9, 2018

Recall

Recall Number
Z-3264-2018
Event Number
80921
Firm
Biomet UK Ltd. Waterton Industrial Estate Bridgend United Kingdom
FEI Number
3002806535
Product Code
JDO
Status
Terminated
Root Cause
Process design
Initiated
August 9, 2018
Terminated
May 12, 2020

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

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

Action

Zimmer Biomet issued US recall notices issued on August 9, 2018 via email and FedEx to Distributors and Hospitals advising of the problem and instruction to remove and return.Your Zimmer Biomet sales representative will remove the affected product from your facility. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]:[email protected].

Distribution

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

Quantity

6 units