PlainRecalls
FDA Devices Moderate Class II Ongoing

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Reported: June 8, 2022 Initiated: May 3, 2022 #Z-1216-2022

Product Description

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Reason for Recall

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

Details

Recalling Firm
Tornier, Inc
Units Affected
1066 units
Distribution
US Nationwide distribution.
Location
Bloomington, MN

Frequently Asked Questions

What product was recalled?
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit. Recalled by Tornier, Inc. Units affected: 1066 units.
Why was this product recalled?
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1216-2022.