SST TWIST DRILL — Class II medical device recall Z-0412-2018
Terminated recall by MicroAire Surgical Instruments, LLC, reported 2018-02-07. One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
| Recall number | Z-0412-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroAire Surgical Instruments, LLC, Charlottesville, VA, United States |
| Recall initiated | 2017-05-22 |
| Classified | 2018-01-26 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-08-29 |
| Quantity | 42 |
| Model numbers | 8054-010 |
Product
SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
Reason for recall
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
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-0412-2018. 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.