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Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment recallZ-0924-2013 · Keystone Dental Inc · initiated Jul 5, 2011

Class II Terminated All recalls posted in March 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Keystone Dental Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Mixed-up of materials/components

What the company is doing

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.

Recall details

Recall number
Z-0924-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 5, 2011
Posted by the FDA
Mar 8, 2013
Recalling firm
Keystone Dental Inc
Quantity
22 units
Product code
NHA
FDA submissions
K101545
Distribution
Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.

Product description

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.

Code information (models, lots, serial numbers)

Lot Number: 2385 Exp Date: 09/2013

Other devices under the same FDA submission

20 devices cleared under K101545 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 64477).

Sources and updates

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