Camlog USA Recalls Uncleared Dental Implant Abutments
Camlog USA is recalling three units of CONELOG Titanbasis CAD/CAM titanium base abutments because the product was not cleared for sale or use in the United States.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Camlog USA is recalling three units of the CONELOG Titanbasis CAD/CAM titanium base abutment, lot 43377. The product is an endosseous dental implant abutment intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants.
The recall was initiated because the product was not cleared for sale or use in the United States. The affected units were distributed in the states of New Hampshire, Maryland, Colorado, and Illinois.
Consumers and healthcare providers who have this specific product should stop using it and contact Camlog USA for further instructions.
The recalled product
- Product
- C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support…
- Manufacturer
- Camlog Usa
- Hazard
- Affected units
- 3
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 43377
Distribution
Part of a larger recall action
This product is one of 4 recalled by Camlog Usa 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 4 products in this recall →Related recalls
Same manufacturer · Camlog Usa
See all →- ModerateCamlog Dental Implant Abutments Recalled for Lack of FDA Clearance
FDA (Devices) · 2013-09-25
- ModerateCamlog USA Recalls Uncleared Dental Implant Abutments in Four States
FDA (Devices) · 2013-09-25
- ModerateCamlog USA Recalls Uncleared Dental Implant Abutments in Four States
FDA (Devices) · 2013-09-25
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