Reported Apr 29, 2015 · Terminated

Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the…

Biomet Spine, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomet Spine, LLC · 310 Interlocken Pkwy Ste 120 · Broomfield, CO · 80021-3464

Is this the product you have?

  • Torque Limiting Handle (Aspen/ Alpine)
  • Model Number 6200-1109 Product UsageProvides posterior fixation in the non-cervical spine with an interspinous fixation device
Lot codes and dates
    • 538133
    • 538134
    • 548080
    • 550475
    • 552169
    • 553131
    • 553710
    • 558873
    • 567568
    • 569141
  • Part Number6200-1109 2009300344 to 2009300543 2009300544 to 2009300643 2009300644 to 2009300743 2009300744 to 2009300843 2009300844 to 2009300993 2009411328 to 2009411377 2010082160 to 2010082257 2010152507 to 2010152571 2010373025 to 2010373174
Amount recalled
874

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 16, 2015 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.