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
FDA Recall Z-3264-2018 · Posted None
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Recalling FirmBiomet UK Ltd.
Recall StatusTerminated
Product CodeJDO
Date Initiated2018-08-09
Date Terminated2020-05-12
Product Quantity6 units
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
Firm 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].
Root Cause
Process design
Distribution Pattern
US Nationwide in the states of AZ, MO, NJ and NM
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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