Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws
Nobel Biocare is recalling 478 Temporary Snap Abutments because packages may contain incorrect screws that could loosen, requiring retightening.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 issue (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 478 pieces of Temporary Snap Abutment Engaging CC RP 1.5 mm (catalog no. 38761). The recall affects lot numbers 13077550 and 13077551. These pre-manufactured prosthetic components are intended to be used in the upper or lower jaw to support tooth replacements and restore chewing function.
The recall was initiated because packages of the 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 nationwide in the United States and in various countries such as Canada, China, and Germany. Consumers and healthcare providers should check their inventory for the specific catalog and lot numbers listed above. If the product is found, it should be removed from use and the abutment retightened with the correct screw if necessary.
The recalled product
- Product
- Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth…
- Manufacturer
- Nobel Biocare Usa Llc
- Affected units
- 478
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.38761
- Lot numbers 13077550 and 13077551
- UDI: (01)07332747115604(10)13077550 and (01)07332747115604(10)13077551
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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