FDA-Device2022-06-08Class II

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Tornier, Inc
Hazard

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

Sold states
US Nationwide distribution.
Affected count
1066 units
Manufactured in
10801 Nesbitt Ave S, N/A, Bloomington, MN, United States
Products
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2022

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