MatrixNEURO Screws - Product Usage: The intended use recall: Labeling Error
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as…
Why was MatrixNEURO Screws - Product Usage: The intended use recalled?
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
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?
Lot # 30P6198
- Product
- MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as…
- Recalling firm
- Synthes, Inc.
- Quantity
- 104 units
- Distribution
- International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
- Recall date
- August 5, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)