Straumann n!ce Zr Dental Implant Abutments Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Straumann USA LLC is recalling 6 units of its Straumann n!ce Zr, HT, Full-arch Restoration due to an incorrect screw seat interface, affecting distribution in several US states.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Straumann USA LLC is recalling its Straumann n!ce Zr, HT, Full-arch Restoration because it includes an incorrect screw seat interface.

Which Products Are Affected

The affected products are Straumann n!ce Zr, HT, Full-arch Restoration, Article 010.0158, which are endosseous dental implant abutments. A total of 6 units are involved, with distribution to AL, AZ, FL, HI, LA, MD, OH, and VA in the United States. The product is identified by UDI: (01)07630031759764(11)YYMMDD(10)XXXXX and project numbers: 28000US_00622_00_b00, 28000US_00431_00_b00, 28000US_00489_00_b00, 28000US_00792_00_b00, 28000US_00908_00_b00, and 28000US_00908_01_b00. The recall number is Z-1995-2026.

What You Should Do

Consumers who have been notified via letter from Straumann USA LLC should follow the instructions provided. For returns or refunds, contact Straumann USA LLC at 60 Minuteman Rd, Andover, MA 01810-1008.

Why This Matters

This recall involves a small number of dental devices, emphasizing the need for accuracy in medical products to ensure patient safety.

Source

This information is from the FDA, recall number Z-1995-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Straumann USA LLC is recalling 6 units of its Straumann n!ce Zr, HT, Full-arch Restoration due to an incorrect screw seat interface, affecting distribution in several US states.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.