FDA Device recall Z-0469-2016
Hook Blade, Angled
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Hook Blade, Angled by Instratek, citing the sterile blade will not fit into the handle provided with the ETTD system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0469-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-24 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instratek |
| Distribution | CO, NY, TX, UT |
Product
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Reason
The sterile blade will not fit into the handle provided with the ETTD system.
Identifiers
| code_info | Lot number MDHZ620 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Instratek
- Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
FDA Device · Class II · 2014-10-01 · Instratek - Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release…
FDA Device · Class II · 2013-03-20 · Instratek
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0469-2016%22
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