Temporary Titanium Abutments May Fracture in Dental Implants
DDS Lab temporary titanium abutments may have been installed in some dental implant restoration cases instead of definitive abutments. The components may fracture, risking restoration loosening, oral tissue injury, and aspiration.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm product. The potential for abutment fracture, restoration loosening, oral tissue injury, and aspiration of fragments represents significant injury risk. No illnesses or injuries have been reported to date, placing this at the High severity level per the rubric criteria for risk-of-harm without yet-reported injury.
Plain-English summary
DDS Lab is recalling temporary titanium abutments that may have been installed in definitive dental implant restoration cases. Approximately 11,259 units were processed between August 2017 and November 2022 and distributed nationwide across all states.
Some restoration cases received a temporary titanium abutment (cylinder) rather than the correct definitive titanium abutment. Temporary abutments are not designed for permanent use and pose a risk of structural failure.
The temporary abutment may fracture, which may lead to loosening of the affixed restoration. If fracturing occurs, fragments could injure the oral mucosa and could potentially be aspirated. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- Temporary Titanium Abutments
- Manufacturer
- DDS Lab
- Affected units
- 11,259
Distribution
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