Reported Jul 27, 2016 · Terminated

MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

Encore Medical, LP

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: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445

Is this the product you have?

  • MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Lot codes and dates
  • Lot
    • 313R1000
    • 313R1900
    • 313R1901
    • 314R1000
    • 314R1900
    • 314R1901
Amount recalled
14 (7 sets)

Where it was sold

Why it was recalled

Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

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 Jan 10, 2017 · Data as of Sep 19, 6:00 PM UTC

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