Straumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect
Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration screw-retained bridge abutments (Article 010.0304) due to an incorrect screw seat interface. Five units were distributed to dental offices in eight states.
What this means for you
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: This is an FDA Class II recall involving a medical device with a structural or functional defect (incorrect screw seat interface) that could lead to implant failure or harm, but the source text does not report any illnesses, injuries, or hospitalizations. The defect represents a risk of harm in a high-consequence product.
Plain-English summary
Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration screw-retained bridge endosseous dental implant abutments, Article 010.0304, due to an incorrect screw seat interface. Five units were involved in the recall.
The product was distributed in the United States to Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio, and Virginia.
Patients who received this abutment should contact their dentist to determine whether they have the affected product and discuss appropriate next steps. Healthcare providers in the affected areas should check their inventory and stop use of the affected abutments.
The recalled product
- Product
- Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
- Manufacturer
- Straumann USA LLC
- Hazard
- device-malfunction
- screw-interface-defect
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 (4)
- 28000US_00811_01_b00
- 28000US_00426_00_b00
- 28000US_00449_00_b00
- 28000US_01266_00_b00.
Distribution
Distributed in 8 states:
- AL
- AZ
- FL
- HI
- LA
- MD
- OH
- VA
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