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.
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: 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
- Affected units
- 5
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
Part of a larger recall action
This product is one of 2 recalled by Straumann 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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