Ortoma AB is recalling 261 units of its Ortoma Inserter and Reamer Adapters (OTD) because a weld between the pin and the inserter holder can break during use. The recall affects models 2001, 1001, 1003, and 1004, which are surgical tools used to help surgeons correctly position hip implants. Surgical staff should stop using these devices immediately and contact Ortoma AB or their distributor for a return or replacement.
A broken weld during a hip replacement surgery can cause the adapter to fail, preventing the proper orientation and placement of the hip implant. This failure could result in surgical delays, improper implant positioning, or the need for additional surgical intervention.
Intended for use with Cup Inserter Tool impactor for hip implant navigation.
Intended for use with Cup Inserter Tool impactor for hip implant navigation.
Intended for use with Cup Inserter Tool impactor for hip implant navigation.
Only distributed outside the U.S. (O.U.S.)
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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