FDAClass IISeptember 16, 2015

Biomet Parsippany recall: Labeling Error

Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

Why was Biomet Parsippany recalled?

Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

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 Number 14-521614B, lot number 375440.

Product
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Recalling firm
Biomet Spine, LLC
Quantity
7 parts
Distribution
Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.
Recall date
September 16, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls