Brand
Straumann USA LLC
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Straumann USA LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-04FDA-DeviceClass IIGM Helix Acqua Implant, Article Number: 140.985
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- 2025-06-04FDA-DeviceClass IIGM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- 2025-06-04FDA-DeviceClass IIPlus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
- 2025-04-30FDA-DeviceClass IIWB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Incorrect blister labelling.
- 2025-04-23FDA-DeviceClass IITLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
The devices are missing the laser marked depth markings.
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