Z-3264-2018Class II

HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole Plate Item Number...

Name: Z-3264-2018 HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole Plate Item Number...
Creator: Biomet UK Ltd.
Published: 2018-08-09
License: https://open.fda.gov/license/

Biomet U.K., Ltd. / initiated 2018-08-09 / Terminated / root cause: manufacturing process

FDA source

Biomet UK Ltd. began a recall of 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... on 2018-08-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3264-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-09
Posted: 2018-09-27
Terminated: 2020-05-12
Recalling firm: Biomet U.K., Ltd.
Product: 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
Product code: JDO Device, Fixation, Proximal Femoral, Implant
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
Root cause tag: manufacturing process
FDA root cause: Process design
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].
Quantity in commerce: 6 units
Distribution: US Nationwide in the states of AZ, MO, NJ and NM
Product codes and lots: Lot Number 3170094 3369699 3622113 3664778 3680647

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3264-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3261-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3262-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3263-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3264-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27

Product code JDO

K080685Class IIHiploc Compression Hip ScrewBiomet Manufacturing, Inc. / cleared 2008-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)