Straumann Recalls 847 Custom Abutment AS Ti Units Due to Material Mix-Up
Summary
Straumann USA LLC initiated a Class II recall of 847 Custom Abutment AS Ti units after discovering a material mix-up during manufacturing. A raw material bar of TAN-material (SAP #701924/Lot 7130439) was incorrectly identified as Titanium Grade 4 bar (SAP #701922/Lot 7130430), resulting in RC Titanium abutments being manufactured with the wrong material. The affected devices were distributed nationwide across 10 US states and Canada.
What changed
Straumann USA LLC initiated a Class II device recall for 847 units of Custom Abutment AS Ti abutments after a manufacturing error resulted in TAN material being used instead of the specified Titanium Grade 4 material. The material substitution occurred when a TAN bar (SAP #701924/Lot 7130439) was misidentified as a Ti Gr4 bar (SAP #701922/Lot 7130430), compromising the material integrity of the finished devices.
Dental healthcare providers and facilities that received these devices should immediately verify their inventory against Catalog Number 010.5438 and associated lot numbers. The use of devices manufactured with incorrect material may pose risks to patient safety in dental implant procedures. Distribution was limited to CA, CO, FL, IA, IL, MN, MO, MT, OR, WA, and Canada, affecting a relatively concentrated geographic area.
What to do next
- Identify and quarantine all Custom Abutment AS Ti devices with Catalog Number 010.5438
- Verify lot numbers 7130439 and 7130430 are not in inventory
- Contact Straumann USA LLC for return and replacement instructions
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-1633-2026 · 20260401 · Ongoing
Product
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
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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