FDAClass IIJanuary 10, 2018

Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres recall

Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C…

Why was Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres recalled?

Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.

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?

Model # 12-31-4012, Lot #133039

Product
Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C…
Recalling firm
Amendia, Inc
Quantity
40 screws
Distribution
Distributed to states of: AL, FL, GA, NY, TX, and VA.
Recall date
January 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls