The Recall Desk
ModerateFDA (Devices)·Z-2205-2013·Announced 2013-09-25

Camlog Dental Implant Abutments Recalled for Lack of FDA Clearance

Camlog USA is recalling six dental implant abutments because they were 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The specific reason for the recall is a regulatory compliance issue (lack of clearance) rather than a reported defect causing injury.

Plain-English summary

Camlog USA is recalling six units of the C2244.4308 CONELOG Titanium Base CC dental implant abutment. The recall is being conducted because the product was not cleared for sale or use in the United States.

The affected units were distributed in the United States to customers in New Hampshire, Maryland, Colorado, and Illinois. The specific lot codes associated with this recall are 4460 and 44163.

Consumers and healthcare providers who have these specific abutments should stop using them and contact Camlog USA for further instructions on how to return or dispose of the product.

The recalled product

Product
C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 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 prostheses in the maxillary and/or mandibul
Manufacturer
Camlog Usa
Affected units
6

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)

  • 4460 and 44163

Distribution

Distributed in 4 states:

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 →

Same manufacturer · Camlog Usa

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