Straumann n!ce Zr HT Dental Implant Abutments Recalled for Incorrect Screw Seat
Straumann USA LLC is recalling 6 units of Straumann n!ce Zr, HT endosseous dental implant abutments (Article 010.0158) due to an incorrect screw seat interface that could affect proper implant function.
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 (dental implant component) with a structural/functional defect (incorrect screw seat interface) that presents a risk of harm to proper implant function, with no reported injuries documented in the source.
Plain-English summary
Straumann USA LLC is recalling Straumann n!ce Zr, HT endosseous dental implant abutments, Article 010.0158, due to an incorrect screw seat interface. The recall involves 6 units distributed to dental providers in Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio, and Virginia.
The incorrect screw seat interface may compromise the proper connection and stability of the implant restoration. Patients and dental professionals should contact their provider if they have received one of these abutments to determine if replacement is necessary.
Affected units can be identified by Article number 010.0158 and the associated project numbers. Straumann USA LLC has initiated this recall as a Class II medical device action.
The recalled product
- Product
- Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
- Manufacturer
- Straumann USA LLC
- Affected units
- 6
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 (5)
- 28000US_00431_00_b00
- 28000US_00489_00_b00
- 28000US_00792_00_b00
- 28000US_00908_00_b00
- 28000US_00908_01_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.
See all 2 products in this recall →Related recalls
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