Recall of Straumann Custom Abutment AS Ti Due to Manufacturing Mix-Up
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 recalls alert 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert 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 alerts 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 recalls advisory 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
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.
Source: FDA Official Notice