Camlog USA Recalls Uncleared Dental Implant Abutments in Four States
Camlog USA is recalling two units of CONELOG Titanium Base CC dental implant abutments because the product was not cleared for sale or use in the United States.
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, which typically corresponds to a moderate severity level where the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Camlog USA is recalling two units of the C2244.3808 CONELOG Titanium Base CC dental implant abutment. 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 United States to the states of New Hampshire, Maryland, Colorado, and Illinois. The product is an endosseous dental implant abutment intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
Consumers and healthcare providers who have this specific product should stop using it and contact Camlog USA for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 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 prostheses in the maxillary and/or mandibula
- Manufacturer
- Camlog Usa
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 2
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)
- 43746
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
FDA (Devices) · 2013-09-25