Straumann USA LLC recalls 7 Custom Abutment AS Ti for Straumann RC. The recall follows a material mix-up during manufacturing. A TAN material bar was incorrectly identified as Titanium Bar Ti Gr4 D, causing RC Titanium abutments to be made with TAN material. Stop using the device and contact Straumann for instructions immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Straumann USA LLC or your healthcare provider for instructions. Notification method: Letter
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Catalog Number/Art.: 010.5438 UDI-DI: 07630031773937 Order numbers (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 Distribution: Worldwide; US states CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; Canada Units recalled: 7 Sold by: Straumann USA LLC Sold since: Unknown Price: Unknown
A material mix-up occurred during manufacturing. A TAN-material bar was misidentified as Titanium Bar Ti Gr4 D. RC Titanium abutments were manufactured using TAN material on Mill-from-Bar Machine 396-06.
No injuries or incidents have been reported.
1. Stop using the product immediately. 2. Contact Straumann USA LLC or your healthcare provider for instructions. 3. Expect recall notice by letter with next steps.
Phone: Unknown. Website: FDA recall page linked in the enforcement report. Hours: Unknown.
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