FDAClass IIMarch 20, 2013

Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment recall: Labeling Error

Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of…

Why was Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment recalled?

Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,

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: 2376 Exp Date: 09/2013

Product
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of…
Recalling firm
Keystone Dental Inc
Quantity
35 units
Distribution
Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
Recall date
March 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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