The Recall Desk
SevereFDA (Devices)·Z-3261-2018·Announced 2018-10-03

Biomet Recalls HipLOC Hip Fracture Fixation System Plates

Biomet UK Ltd. is recalling specific HipLOC hip fracture fixation system plates due to an undersized bore that prevents the lag screw from fitting.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving structural defects in medical devices are assigned a severity score of 4 (Severe).

Plain-English summary

Biomet UK Ltd. is recalling the HipLOC Hip Fracture Fixation System, specifically the Hiploc System 130 Plate 38 mm Barrel 4 Hole Plate (Item Number: 2110-130-004). The recall affects 1 unit from Lot Number 3222008. The product is indicated for the fixation of bone fractures, including intracapsular, intertrochanteric, and subtrochanteric fractures of the proximal femur.

The recall is being issued because the plate barrel has an undersized bore. This defect can result in the lag screw not fitting through the barrel. The agency has classified this as a Class II recall.

The affected product was distributed in the United States in the states of Arizona, Missouri, New Jersey, and New Mexico. Healthcare providers and patients should contact Biomet UK Ltd. for further instructions regarding the return or replacement of the affected device.

The recalled product

Product
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 f
Manufacturer
Biomet UK Ltd.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 3222008

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Biomet UK Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Biomet UK Ltd.

See all →

Same hazard · structural defect

See all →