FDAClass IIJanuary 25, 2017

Alteon Neck Preserving Stem recall

Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

Why was Alteon Neck Preserving Stem recalled?

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

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?

Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776

Product
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Recalling firm
Exactech, Inc.
Quantity
98
Distribution
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Recall date
January 25, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls