Reported Jan 22, 2014 · Terminated

Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

Biomet, Inc.

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, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Lot codes and dates
  • Catalog Number816135038 (8161-35-038)
  • Lot Number IdentificationRM244D
Amount recalled
52

Where it was sold

Why it was recalled

3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

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 Jul 7, 2015 · Data as of Sep 19, 4:45 PM UTC

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