CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report

Genesis Straight Esthetic mm Cuff Abutment recalled by Keystone Dental

Keystone Dental is recalling Genesis Straight Esthetic mm Cuff Abutment, distributed nationwide in the US. The recall was initiated on 5 Jul 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 2385 Exp Date: 09/2013

Quantity recalled22 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0924-2013
FDA event ID: 64477
Recalling firm: Keystone Dental, Burlington, MA
Classification: Class II
Status: Terminated
Recall initiated: 5 Jul 2011
FDA classified: 8 Mar 2013
Reported: 20 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: FAX
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

5 Jul 2011	Recall initiated by company
8 Mar 2013	Classified by FDA	+612 days
20 Mar 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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 of of bone in partially or fully edentulous mandibles and maxillae.

Where it was distributed

Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.

Nationwide California Indiana Massachusetts Maryland Michigan Minnesota North Carolina New Hampshire New York Pennsylvania Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Number: 2385 Exp Date: 09/2013

Where was it sold?

Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 64477

Reported	Class	Recall	Company	Reason	Where
20 Mar 2013	CLASS II	Genesis Straight Esthetic Cuff Abutment recalled by Keystone Dental	Keystone Dental	Labeling Errors	Nationwide

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