Nobel Biocare Recalls Dental Abutments Due to Incorrect Screw Risk
Nobel Biocare is recalling 227 Esthetic Abutment CC RP 1.5 mm units because they may contain incorrect screws that could loosen.
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, but the source text describes a mechanical defect (incorrect screw) with a specific corrective action (retightening) and does not report any injuries, hospitalizations, or structural failures, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 227 pieces of Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components, catalog number 36669. These dental implant abutments are intended to be used in the upper or lower jaw to support tooth replacements and restore chewing function.
The recall is issued because packages of these abutments may contain an incorrect screw. While the incorrect screw will tighten, it cannot be guaranteed that it will not loosen. If the screw loosens, the abutment should be retightened with the correct screw.
The affected units were distributed worldwide, including nationwide in the United States and in specific countries such as Canada, China, and Germany. Consumers and dental professionals should check their inventory for catalog number 36669 and lot number 13077560. If the product is identified, it should be returned to the distributor or manufacturer for replacement or credit.
The recalled product
- Product
- Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Affected units
- 227
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 (3)
- Catalog no. 36669
- Lot no. 13077560
- UDI: (01)07332747032598(10)13077560
Distribution
Part of a larger recall action
This product is one of 6 recalled by Nobel Biocare Usa Llc 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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