Recall of Straumann Custom Abutment AS Ti Due to Manufacturing Mix-Up
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Straumann USA LLC is recalling 7 units of Custom Abutment AS Ti due to a material mix-up in manufacturing, affecting distribution in several U.S. states and Canada.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States and Canada. 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, fda, Devices.
What Happened
A material mix-up occurred during the manufacturing of Straumann Custom Abutment AS Ti, where a TAN-material bar was incorrectly used instead of a Titanium bar.
Which Products Are Affected
The affected product is Custom Abutment AS Ti, for Straumann RC, including TAN screw, with Catalog Number 010.5438. A total of 7 units are involved. The products have UDI-DI: 07630031773937 and affected lots include: 71315US_00729_01_b00, 91076US_03269_00_b00, 72509US_01048_00_b00, 72839US_00065_00_b00, 39133US_11508_02_b00, 4202CA_00558_00_b00, 72630CA_00109_00_b00. Distribution was nationwide in the United States, specifically in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA, and in Canada. The official recall number is Z-1633-2026.
What You Should Do
Consumers who have the affected products should follow the instructions in the initial firm notification letter from Straumann USA LLC.
Why This Matters
This recall underscores the potential risks associated with manufacturing errors in medical devices, which could lead to adverse health consequences, though the probability is considered remote based on FDA classification.
Source
Attribution: FDA. For more information, refer to FDA Recall Number Z-1633-2026.
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 (1,246 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.