Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Recalled by ORTOMA AB Due to Due to a weld breakage between the pin...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ORTOMA AB directly.
Affected Products
Ortoma 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 intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.
Quantity: 261 devices
Why Was This Recalled?
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ORTOMA AB
ORTOMA AB has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report