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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann n!ce PMMA Fullarch Restoration

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 Class 2 Device Recall Straumann n!ce PMMA Fullarch Restorationsee related information
Date Initiated by FirmMarch 27, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1995-2026
Recall Event ID 98681
510(K)NumberK222836 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductStraumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Code Information Article 010.0158. UDI: (01)07630031759764(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00622_00_b00, 28000US_00431_00_b00, 28000US_00489_00_b00, 28000US_00792_00_b00, 28000US_00908_00_b00, 28000US_00908_01_b00.
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactJennifer M. Jackson
978-747-2560
Manufacturer Reason
for Recall		Includes an incorrect screw seat interface.
FDA Determined
Cause 2		Under Investigation by firm
ActionStraumann USA notified consignees on about 03/27/2026 via telephone call, mailed letter, or email. Consignees were instructed to examine inventory for affected product, cease use and quarantine any affected units on hand, arrange for the return of all affected units and complete and return the provided Customer Confirmation Form. Consignees were also instructed to no contact Straumann contact Jennifer Jackson to organize a remake of the units, if any were used. Once the new restoration is available, schedule the patient to replace the restoration.
Quantity in Commerce6 units
DistributionUS distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHA
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