ORTOMA AB recalled 261 Inserter Adapters on July 28, 2025, due to a potential weld failure. The defect poses a risk of improper positioning during hip implant procedures. The recall affects devices distributed worldwide, including the U.S. and countries like Japan and Sweden.
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ORTOMA AB or your healthcare provider for instructions. Notification method: Letter
The recall includes Inserter Adapter OTD Straight REF 30-201 (Model Number: 2001), OTD Pinnacle Straight REF 30-202 (Model Number: 1001), Reamer Adapter OTD REF 30-157 (Model Number: 1003), and Inserter Adapter OTD REF 30-158 (Model Number: 1004). These devices are intended for use with a Cup Inserter Tool and were distributed worldwide.
The recall stems from a weld breakage between the pin and inserter holder of the Inserter Adapter. This defect may lead to improper positioning of hip implants, which can compromise surgical outcomes.
There have been no reported injuries or incidents associated with the recalled Inserter Adapters at this time.
Patients and healthcare providers should stop using the Inserter Adapters immediately. Follow the recall instructions provided by the manufacturer and contact ORTOMA AB or your healthcare provider for further instructions.
For questions regarding this recall, contact ORTOMA AB directly or visit their website. Information is also available through the FDA's recall portal.
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