Reported Jun 8, 2022 · Ongoing

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Tornier, 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: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109

Is this the product you have?

  • Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Lot codes and dates
  • ModelMWJ128, Ratcheting Screwdriver Handle, all lot codes
Amount recalled
1066 units

Where it was sold

  • Nationwide

Why it was recalled

The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.

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

Data as of Sep 19, 6:56 PM UTC

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