Ratcheting Screwdriver Handle — Class II medical device recall Z-1216-2022
Ongoing recall by Tornier, Inc, reported 2022-06-08, distributed nationwide. The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap contai
| Recall number | Z-1216-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2022-05-03 |
| Classified | 2022-06-01 |
| Reported by FDA | 2022-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,066 units |
| Model numbers | MWJ128 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1216-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.