Recall of Straumann n!ce PMMA Full-arch Restoration
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Straumann USA LLC is recalling 5 units of the Straumann n!ce PMMA Full-arch Restoration due to an incorrect screw seat interface, affecting distribution in several U.S. 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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Recall of Straumann n!ce PMMA Full-arch Restoration
What Happened
Straumann USA LLC is recalling the Straumann n!ce PMMA Full-arch Restoration because it includes an incorrect screw seat interface.
Which Products Are Affected
The affected product is the Straumann n!ce PMMA Full-arch Restoration, Screw-retained Bridge, Article 010.0304, which is an Endosseous Dental Implant Abutments. A total of 5 units are involved. The product has the following code information: Article 010.0304, UDI: (01)07630031779977(11)YYMMDD(10)XXXXX, and Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00. Distribution occurred in the United States to the states of AL, AZ, FL, HI, LA, MD, OH, and VA.
What You Should Do
Consumers should contact Straumann USA LLC for further instructions, as the recall was initiated via letter. The firm's address is 60 Minuteman Rd, Andover, MA 01810-1008. For returns or refunds, reach out to the recalling firm using this information.
Why This Matters
This recall involves a medical device used in dental procedures, highlighting potential risks associated with incorrect components that could affect patient safety.
Source
Attribution: FDA. For more information, visit the FDA website at the recall page for number Z-1994-2026.
Original source: FDA Official Notice ↗
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