FDA Medical Device Recalls (openFDA)
Instratek, Incorporated: Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
- Recall number
- Z-0469-2016
- Recalling firm
- Instratek, Incorporated
- Product
- Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
- Status
- Terminated
- Initiated
- 2015-11-24
- Posted
- 2015-12-22
- Terminated
- 2016-06-27
- Reason
- The sterile blade will not fit into the handle provided with the ETTD system.
- Root cause
- Employee error
- Action
- Instratek contacted customers by phone call either by direct contact or voice mail message on November 23, 2015. that a recall was being initiated. Formal letters were sent via UPS to the Customers annoucing the recall on November 24, 2015. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product,please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You should contact lnstratek's Customer service for a return authorization number and further instructions for return of unused product.
- Quantity
- 39 units
- Distribution
- US distribution to the states: TX, UT, NY and CO.
- Lot, serial or model codes
- Lot number MDHZ620
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1000118334
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28