Mini Cannulated Titanium Headed and Headless Screw Set recall
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
Why was Mini Cannulated Titanium Headed and Headless Screw Set recalled?
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
- 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
- Recalling firm
- Instratek, Incorporated
- Quantity
- 96
- Distribution
- Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
- Recall date
- October 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)