CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
Straumann n!ce Zr, HT, Full-arch Restoration recalled
Straumann USA is recalling Straumann n!ce Zr, HT, Full-arch Restoration, distributed in 8 states. The recall was initiated on 27 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1995-2026
- FDA event ID
- 98681
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Mar 2026
- FDA classified
- 29 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 27 Mar 2026 | Recall initiated by company | |
| 29 Apr 2026 | Classified by FDA | +33 days |
| 6 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Includes an incorrect screw seat interface.
Product as listed by the FDA
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Where it was distributed
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Questions about this recall
Is Straumann n!ce Zr, HT, Full-arch Restoration recalled?
Yes. Straumann USA recalled Straumann n!ce Zr, HT, Full-arch Restoration on 27 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1995-2026.
Why was it recalled?
Includes an incorrect screw seat interface.
Which lots are affected?
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.
Where was it sold?
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Straumann USA
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|---|---|---|---|---|---|
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | Straumann Bone Level Tapered (BLT) Implant, D RC, SLActive recalled | Straumann USA | Other | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Custom Abutment AS Ti, for Straumann RC, incl recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | Custom Abutment Ti, for Straumann RC, incl recalled | Straumann USA | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: Dental Pack recalled by Medline Industries | Medline Industries | Sterility | Nationwide |