FDA Class II: Straumann Recalls 847 Custom Abutment Ti Units
Summary
Straumann USA LLC initiated a Class II device recall for 847 Custom Abutment Ti units (catalog 027.4620) due to a material mix-up during manufacturing. A raw material bar of TAN (SAP #701924/Lot 7130439) was incorrectly identified as Titanium Grade 4 (SAP #701922/Lot 7130430), resulting in abutments manufactured with wrong material. Affected products were distributed nationwide to CA, CO, FL, IA, IL, MN, MO, MT, OR, WA and Canada.
What changed
Straumann discovered a manufacturing material identification error where a bar of TAN material (SAP #701924/Lot 7130439) was incorrectly labeled as Titanium Grade 4 bar during abutment production. This resulted in RC Titanium abutments being manufactured with TAN material instead of the specified titanium alloy.
Dental providers, oral surgeons, and periodontists who use Straumann's Custom Abutment Ti system must immediately identify affected products by lot number and remove them from clinical use. Device distributors should alert their customer base. Straumann must ensure proper material verification controls are implemented to prevent recurrence. The recall affects approximately 847 units distributed across 10 US states and Canada.
What to do next
- Identify and quarantine all Custom Abutment Ti units (catalog 027.4620, Lot 7130439) in inventory
- Notify affected dental practitioners and patients who received the recalled devices
- Contact Straumann for return/replacement instructions and report adverse events to FDA MedWatch
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Straumann USA LLC
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1632-2026 · 20260401 · Ongoing
Product
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Reason for Recall
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manu...
Distribution
Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
Source: openFDA Enforcement API
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Source document text, dates, docket IDs, and authority are extracted directly from STRAUMANN.
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