Tornier, Inc. is recalling 233 units of Tornier HRS Max shoulder replacement parts because they were incorrectly labeled. These components are actually compatible only with the older Tornier HRS system and will not fit or function correctly with the newer Tornier HRS Max system. No incidents or injuries have been reported to date, but the company is voluntarily recalling the affected catalog and lot numbers to prevent surgical complications.
Using these incorrectly labeled parts during a shoulder replacement surgery could lead to improper fit or device failure because the components are physically incompatible with the intended HRS Max system.
Incorrectly labeled as compatible with HRS Max system.
Incorrectly labeled as compatible with HRS Max system.
Incorrectly labeled as compatible with HRS Max system.
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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