Hip Implant Surgical Adapter Recalled Due to Weld Defect
ORTOMA AB recalls Ortoma Inserter Adapter OTD hip surgical devices due to weld breakage between the pin and inserter holder. The defect affects 261 devices distributed in Florida and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device with a structural weld defect that poses a risk of device failure during hip implant surgery. No injuries or hospitalizations have been reported, meeting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Ortoma AB is recalling Ortoma Inserter Adapter OTD devices, which are surgical instruments used during hip implant placement procedures. The devices are designed to attach to a Cup Inserter Tool to help position the hip implant cup during surgery.
The recall is due to weld breakage between the pin and inserter holder. This structural defect in the adapter could affect device performance during surgical procedures.
A total of 261 devices have been recalled. These devices were distributed in Florida within the United States, as well as in Japan and Sweden. The recall includes multiple models with specific lot numbers identified by the FDA.
Healthcare providers and surgical centers using these devices should check their inventory against the affected lot numbers and device model numbers. Contact ORTOMA AB or the FDA for guidance on device replacement or proper handling of recalled units.
The recalled product
- Product
- 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-
- Manufacturer
- ORTOMA AB
- Hazard
- structural-defect
- weld-failure
Distribution
Distributed nationwide across the United States.
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