FDAClass IIMarch 20, 2013

Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment recall: Labeling Error

Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types…

Why was Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment recalled?

Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm 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: 2385 Exp Date: 09/2013

Product
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types…
Recalling firm
Keystone Dental Inc
Quantity
22 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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