Z-1216-2022 Class II Ongoing
FDA device recall Z-1216-2022 was initiated by Tornier, Inc on May 3, 2022 and is designated Class II. Reason for recall: The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. The recall status is ongoing. Affected quantity: 1066 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2022
- Initiation Date
- May 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1066 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1216-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026