FDAClass IIJanuary 10, 2018

CER Option Type 1 TPR Sleve -6 recall

CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064

Why was CER Option Type 1 TPR Sleve -6 recalled?

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

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 Number: 854540

Product
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Recalling firm
Zimmer Biomet, Inc.
Quantity
N/A
Distribution
Nationwide in US; Internationally Argentina, Netherlands & Canada
Recall date
January 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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