Device product
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Z-1216-2022
Product summary
- Firm
- Tornier, Inc
- Event
- Event 90052
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1066 units
- Official record key
device-enforcement:Z-1216-2022
Official wording
Reason: The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Code information: Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.