Recall of Straumann Custom Abutment Ti Devices
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Straumann USA LLC is recalling 13 units of Custom Abutment Ti devices due to a material mix-up during manufacturing.
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, cpsc, Devices.
What Happened
Straumann USA LLC is recalling the Custom Abutment Ti devices because a material mix-up occurred during manufacturing, where a TAN-material bar was incorrectly used instead of a Titanium Bar Ti Gr4.
Which Products Are Affected
The affected product is Custom Abutment Ti, for Straumann RC, including TAN screw, with Catalog Number/Art.: 027.4620. A total of 13 units are involved, distributed in the US states of CA, CO, FL, IA, IL, MN, MO, MT, OR, and WA, as well as Canada. The recall includes UDI-DI: 07630031713766 and specific order numbers: 92465US_12039_00_b00, 92465US_12040_00_b00, 92465US_12047_00_b00, 92465US_12048_00_b00, 70959US_02227_00_b00, 94021US_02348_00_b00, 70416US_07543_00_b00, 91395US_01687_00_b00, 91545US_03284_00_b00, 91545US_03285_00_b00, 71711US_00420_00_b00, 91853US_06313_00_b00, and 72747US_00247_00_b00. The official recall number is Z-1632-2026.
What You Should Do
Affected customers should follow the firm's initial notification, which was sent via letter, for further instructions on the voluntary recall.
Why This Matters
This recall involves a manufacturing error that could affect the quality of medical devices, potentially impacting patient safety in a way that is not immediately life-threatening.
Source
FDA recall notice Z-1632-2026
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 (1,308 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.