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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80921

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet UK Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 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-3261-2018
Recall number
Z-3261-2018
Initiated
August 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
Biomet UK Ltd.
Quantity
1 unit

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Lot Number: 3222008

Distribution pattern

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

device · product 2 of 4

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

Z-3262-2018
Recall number
Z-3262-2018
Initiated
August 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
Biomet UK Ltd.
Quantity
10 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Lot Number: 3680822 3680823 3680824 3680825 3700273

Distribution pattern

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

device · product 3 of 4

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
Recall number
Z-3263-2018
Initiated
August 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
Biomet UK Ltd.
Quantity
44 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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

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

device · product 4 of 4

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

Z-3264-2018
Recall number
Z-3264-2018
Initiated
August 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
Biomet UK Ltd.
Quantity
6 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Lot Number 3170094 3369699 3622113 3664778 3680647

Distribution pattern

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