epa_echo
1 records
fda
6 records
FDA Device Recall: Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027
2026-04-01
Class II — 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 ide...
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FDA Device Recall: WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
2026-02-18
Class III — The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
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FDA Device Recall: Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
2025-12-03
Class II — The possibility for this product that is intended for demonstration purposes only to be placed in patients.
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FDA Device Recall: Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
2022-01-26
Class II — Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm impl...
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FDA Device Recall: Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant
2022-01-26
Class II — Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm impl...
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FDA Device Recall: Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number
2015-01-21
Class II — Drill set may contain incorrect drill.
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ny_corps
1 records
NY Corp: STRAUMANN USA, LLC
2017-04-13
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Delaware
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