The Recall Desk
HighFDA (Devices)·Z-3262-2018·Announced 2018-10-03

Biomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues

Biomet UK Ltd. is recalling 10 units of HipLOC Hip Fracture Fixation System plates due to an undersized bore that prevents the lag screw from fitting.

What this means for you

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 is classified as FDA Class II. The hazard involves a mechanical defect (undersized bore) that prevents proper assembly of the implant, posing a risk of harm during surgical fixation, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet UK Ltd. is recalling 10 units of the HipLOC Hip Fracture Fixation System, specifically the 135° Plate 38 mm Barrel 3 Hole Plate (Item Number: 2110-135-003). The recall is due to an undersized bore on the HipLOC plate barrel, which can result in the lag screw not fitting through the barrel.

The affected products were distributed in the United States in the states of Arizona, Missouri, New Jersey, and New Mexico. The specific lot numbers involved are 3680822, 3680823, 3680824, 3680825, and 3700273.

This recall is classified as Class II by the FDA. Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have already received this implant should contact their healthcare provider for evaluation.

The recalled product

Product
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 f
Manufacturer
Biomet UK Ltd.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10

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: 3680822 3680823 3680824 3680825 3700273

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 · mechanical defect

See all →