Ortoma AB is recalling 261 Inserter Adapters for the Cup Inserter Tool used in hip replacement procedures sold worldwide, including Florida. The defect is weld breakage between the pin and the inserter holder. Surgeons and patients should stop using the devices immediately and follow the manufacturer's recall instructions.
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
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This device set is used to attach to a Cup Inserter Tool during hip replacement surgery to guide alignment of the implant cup.
A weld break between the pin and inserter holder can cause misalignment of the hip cup during implantation, potentially affecting outcomes.
This recall is not described as part of a broader industry pattern in the notice.
The recall may affect surgical workflows and necessitate recalling and replacing affected adapters to ensure proper cup placement.
UDI-DI codes and model numbers on device labeling and packaging; recall notice from Ortoma AB and FDA page.
Remedy processing and replacement or instructions may take several weeks; follow manufacturer guidance.
Save recall notice, product labels, UDI-DI codes, and all correspondence with Ortoma AB or healthcare providers.
Models: 2001, 1001, 1003, 1004. UDI-DI codes: 07350137521019; 07350137520593; 07350137520081; 07350137520098. Distribution: Worldwide; U.S. Florida; Japan; Sweden. Recall date: 2025-07-28. Quantity: 261 devices. Classification: Class II. Remed y: Stop using the device and follow manufacturer instructions. Brand: Ortoma AB.
No injuries or incidents have been reported.
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