Z-0924-2013Class II

Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or...

Name: Z-0924-2013 Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or...
Creator: Keystone Dental Inc
Published: 2011-07-05
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2011-07-05 / Terminated / root cause: labeling and UDI

FDA source

Keystone Dental Inc began a recall of 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... on 2011-07-05. FDA classified it as Class II and gives the reason as "Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0924-2013
Classification: Class II
Status: Terminated
Initiated: 2011-07-05
Posted: 2013-03-08
Terminated: 2013-03-11
Recalling firm: Keystone Dental Inc.
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 of of bone in partially or fully edentulous mandibles and maxillae.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Keystone issued Market Withdrawal notice via fax on July 5, 2011, to affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the fax-back form to facilitate whether they hae any affected product and indicate whether they would like to receive a replacement of a full refund. Customers ewre asked to contact Keyston'es Customer Relations Department to coordinate shipment of the returned product. For questions regarding this recall call 781-328-3390.
Quantity in commerce: 22 units
Distribution: Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
Product codes and lots: Lot Number: 2385 Exp Date: 09/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0924-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0923-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08
Z-0924-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

Product code NHA

K101545Class IIGenesis Implant SystemKeystone Dental / cleared 2010-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)