Brand
ORTOMA AB
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for ORTOMA AB and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-01FDA-DeviceClass IIOrtoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
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