Hook Blade — Class II medical device recall Z-0469-2016
Terminated recall by Instratek, Incorporated, reported 2015-12-30, distributed in CO, NY, TX, UT. The sterile blade will not fit into the handle provided with the ETTD system.
| Recall number | Z-0469-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instratek, Incorporated, Houston, TX, United States |
| Recall initiated | 2015-11-24 |
| Classified | 2015-12-22 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-06-27 |
| Distributed | CO, NY, TX, UT |
| Quantity | 39 units |
| Reason classes | sterility |
| Lot numbers | MDHZ620 |
| Model numbers | 7058A |
Product
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Reason for recall
The sterile blade will not fit into the handle provided with the ETTD system.
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-0469-2016. 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.