Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Scr
FDA device recall Z-2679-2014 · posted 2014-09-22 · Terminated
Recall details
- Recalling firm
- Instratek, Incorporated
- Reason for recall
- Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 96
- Distribution
- Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
- Date initiated
- 2013-04-25
- Date posted
- 2014-09-22
- Date terminated
- 2016-01-26
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINI CANNULATED HEADED AND HEADLESS SCREW SET (K120493) | Instratek, Inc. | 2012-05-17 |