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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- 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
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.
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