Recall Z-1216-2022— Tornier, Inc

Name: FDA recall Z-1216-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-03

Class II · Ongoing

Class II FDA medical device recall by Tornier, Inc, initiated 2022-05-03. It names one FDA 510(k) clearance: K161742. Product: Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit. Reason: The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-05-03
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K161742 — Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.·cleared 2016-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.