The Recall Desk
ModerateFDA (Devices)·Z-1466-2015·Announced 2015-04-29

Biomet Recalls Torque Limiting Handles for Spinal Fixation Devices

Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.

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 a voluntary precautionary recall due to supplier component updates, with no reported injuries or illnesses.

Plain-English summary

Biomet Spine, LLC is recalling 874 units of the Torque Limiting Handle (Aspen/Alpine) Model Number 6200-1109. This medical device is used to provide posterior fixation in the non-cervical spine with an interspinous fixation device.

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 across the United States.

Healthcare providers and patients should stop using the affected handles and contact Biomet Spine for further instructions or replacement units.

The recalled product

Product
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
Manufacturer
Biomet Spine, LLC
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
874

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 (9)

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

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 →

Related recalls

Same manufacturer · Biomet Spine, LLC

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Same hazard · component defect

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