Recall of Straumann n!ce PMMA Full-arch Restoration
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 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,343 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.