The Recall Desk
ModerateFDA (Devices)·Z-1465-2015·Announced 2015-04-29

Biomet Recalls Lineum HF Torque Handle Limit Due to Component Updates

Biomet Spine is recalling 148 Lineum HF Torque Handle Limit units because the supplier withdrew the product for component updates or reconfiguration.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is driven by a supplier withdrawal for component updates rather than a reported safety hazard or injury, fitting the criteria for a voluntary precautionary recall or minor issue.

Plain-English summary

Biomet Spine, LLC is recalling 148 units of the Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035. The recall also covers the Torque Limiting Handle (Aspen/Alpine). These medical devices are designed to facilitate the reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, rods, hooks, and lateral connectors.

The recall was initiated because the supplier withdrew the product from the market for component updates or reconfiguration. The affected units were distributed worldwide and nationwide in the United States.

No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The recall is classified as Class II by the FDA.

The recalled product

Product
Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
Manufacturer
Biomet Spine, LLC
Category
Medical Device — Spinal Instrumentation
Hazard
Affected units
148

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 (10)

  • 538133
  • 538134
  • 548080
  • 550475
  • 552169
  • 553131
  • 553710
  • 558873
  • 567568
  • 569141

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Biomet Spine, LLC 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 2 products in this recall →

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