Mini Cannulated Titanium Headed and Headless Screw Set and… recallZ-2679-2014 · Instratek, Incorporated · initiated Apr 25, 2013
Class II Terminated All recalls posted in September 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Instratek, Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2679-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 25, 2013
- Posted by the FDA
- Sep 22, 2014
- Recalling firm
- Instratek, Incorporated
- Quantity
- 96
- Product code
- HWC
- FDA submissions
- K120493
- Distribution
- Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Product description
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
Code information (models, lots, serial numbers)
Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
Other devices under the same FDA submission
8 devices cleared under K120493 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MINI IC2516Stryker GmbH · Screw, fixation, bone1 report
- MINI IC3038Stryker GmbH · Screw, fixation, bone1 report
- MINI IC3040Stryker GmbH · Screw, fixation, bone1 report
- MINI IH2540Stryker GmbH · Screw, fixation, bone1 report
- MINI IH3040Stryker GmbH · Screw, fixation, bone1 report
- MINI KN1116Stryker GmbH · Screw, fixation, bone1 report
- MINI IH4040Stryker GmbH · Screw, fixation, bone1 report
- MINI KN1115Stryker GmbH · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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