The Recall Desk
ModerateFDA (Devices)·Z-0923-2013·Announced 2013-03-20

Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments

Keystone Dental Inc is recalling 35 units of Genesis Straight Esthetic abutments because they were mislabeled as 4.0 mm 1 mm cuff units when they are actually 5.0 mm 3 mm cuff units.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to mislabeling with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Keystone Dental Inc is recalling 35 units of Genesis Straight Esthetic 4.0 mm 1 mm Cuff Abutments (Part Number: G71200). The recall is due to mislabeling; the products were labeled as 4.0 mm 1 mm cuff abutments but are actually Genesis Straight Esthetic 5.0 mm Contour, 3 mm cuff abutments.

The affected units are identified by Lot Number 2376 and have an expiration date of 09/2013. These products were distributed nationwide, including in California, Indiana, Massachusetts, Maryland, Minnesota, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, and Wisconsin.

Dental professionals and patients should stop using these specific abutments and contact Keystone Dental Inc for instructions on return or replacement. The mislabeling could lead to the use of the wrong size abutment during surgical procedures.

The recalled product

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 of bone in partially or fully edentulous mandibles and maxillae.
Affected units
35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 2376 Exp Date: 09/2013

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Keystone Dental Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →