Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments
Keystone Dental Inc is recalling 22 units of Genesis Straight Esthetic abutments that were mislabeled with incorrect dimensions.
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, and the hazard is a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Keystone Dental Inc is recalling 22 units of Genesis Straight Esthetic 5.0 mm 3.0 mm Cuff Abutments, Part Number G71205. The recall is due to mislabeling; the products were labeled as 5.0 mm 3.0 mm cuff abutments but were actually Genesis Straight Esthetic 4.0 mm Contour, 1 mm cuff abutments.
The affected units are identified by Lot Number 2385 and 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.
Consumers and dental professionals should stop using these specific abutments and contact Keystone Dental Inc for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 22
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: 2385 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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