FDA Medical Device Recalls (openFDA)
Instratek, Incorporated: 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
- Recall number
- Z-2679-2014
- Recalling firm
- Instratek, Incorporated
- Product
- 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
- Status
- Terminated
- Initiated
- 2013-04-25
- Posted
- 2014-09-22
- Terminated
- 2016-01-26
- Reason
- Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
- Root cause
- Nonconforming Material/Component
- Action
- The firm plans to notify their customers of the recall via email, telephone and visit. The firm then plans to scrap and discard any affected product.
- Quantity
- 96
- Distribution
- Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
- Lot, serial or model codes
- Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
- 510(k) numbers
- ["K120493"]
- PMA numbers
- not on file
- Product code
- HWC
- 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