Recall of Straumann Custom Abutment Ti Devices

FDA Recalls medium FDA · · United States and Canada

Straumann USA LLC is recalling 13 units of Custom Abutment Ti devices due to a material mix-up during manufacturing.

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

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

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
Straumann USA LLC is recalling 13 units of Custom Abutment Ti devices due to a material mix-up during manufacturing.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States and Canada. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.