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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Get instant alerts for recalls that affect you. Free forever.
Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.
Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.
Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.
Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.
CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.
Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.
Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.
Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.