The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3264-2018·Announced 2018-10-03

Biomet Recalls HipLOC Hip Fracture Fixation System Plates

Biomet UK Ltd. is recalling 6 units of HipLOC System 140° Plates due to an undersized bore that prevents the lag screw from fitting through the barrel.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect that could prevent proper fracture fixation. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Biomet UK Ltd. is recalling 6 units of the HipLOC Hip Fracture Fixation System, specifically the Hiploc System 140° Plate 38 mm Barrel 4 Hole Plate (Item Number: 2110-140-004). The recall is due to a manufacturing defect where the bore on the HipLOC plate barrel is undersized. This defect can result in the lag screw not fitting through the barrel, which may prevent the device from functioning as intended for the fixation of bone fractures.

The affected units were distributed nationwide in the United States, specifically in the states of Arizona, Missouri, New Jersey, and New Mexico. The recall covers units associated with lot numbers 3170094, 3369699, 3622113, 3664778, and 3680647. The HipLOC Compression Hip Screw is indicated for open reduction and internal fixation of proximal femur fractures, including intracapsular, intertrochanteric, and subtrochanteric fractures.

Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers. If the affected units are found, they should be removed from use and returned to Biomet UK Ltd. according to the recall instructions. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

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…
Manufacturer
Biomet UK Ltd.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
6

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 3170094 3369699 3622113 3664778 3680647

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 →

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