United StatesCustom Abutment Ti for Straumann RC (Catalog No. 027.4620, UDI‑DI 07630031713766; specified order/lot numbers listed) and Custom Abutment AS Ti for Straumann RC (Catalog No. 010.5438, UDI‑DI 07630031773937; specified order/lot numbers listed) are recalled; affected units were distributed in the U.S. and Canada. The recall was issued because a TAN raw material bar was incorrectly identified as a Titanium bar, so RC Titanium abutments were manufactured from TAN material.
What's being recalled
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Recalling firm: Straumann USA LLC, Andover, MA, United States.
How to identify it
Catalog Number/Art.: 027.4620; UDI-DI: 07630031713766; Order number (lot): 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 , 72747US_00247_00_b00; Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (lot): 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;
The hazard
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 manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)