Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
Nobel Biocare is recalling 236 units of temporary dental implant abutments because packages may contain an incorrect screw 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, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 236 units of Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components, catalog number 36662. The recall is due to a potential issue where packages of abutments may contain an incorrect screw.
While the incorrect screw will tighten, it cannot be guaranteed that the screw will not loosen. If the screw loosens, the abutment should be retightened with the correct screw. The affected products were distributed worldwide, including in the United States and various international locations.
Consumers and healthcare providers should check their inventory for catalog number 36662, lot number 13078005, and UDI (01)07332747034301(10)13078005. If the product is found, it should be handled according to the recall instructions to ensure the correct screw is used for retightening if necessary.
The recalled product
- Product
- Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to r
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Affected units
- 236
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. 36662
- Lot no. 13078005
- UDI: (01)07332747034301(10)13078005
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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