FDA Device recall Z-1216-2022
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
- FDA Device
- Class II
- ongoing
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit by Tornier, citing the device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1216-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-03 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tornier |
| Distribution | US |
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.
Identifiers
| code_info | Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.