FDAClass IIAugust 5, 2020

MatrixMIDFACE Screws - Product Usage: The intended use recall

MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as…

Why was MatrixMIDFACE Screws - Product Usage: The intended use recalled?

One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).

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 # 41P2340

Product
MatrixMIDFACE 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 Produktions GmbH
Quantity
41 units
Distribution
International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Recall date
August 5, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls