Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
Nobel Biocare is recalling 239 units of Temporary Abutment Engaging CC RP components because packages 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. The hazard involves a potential mechanical failure (loosening screw) that requires corrective action (retightening) but does not present an immediate risk of serious injury or death, fitting the Moderate criteria for low-risk mechanical issues.
Plain-English summary
Nobel Biocare USA LLC is recalling 239 units of Temporary Abutment Engaging CC RP pre-manufactured prosthetic components, catalog no. 36664. 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 the 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. The specific lot number is 13077622. Consumers and healthcare providers should check their inventory for this specific catalog and lot number.
The recalled product
- Product
- Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to res
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Affected units
- 239
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. 36664
- Lot no. 13077622
- UDI: (01)07332747034301(10)13077622
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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