Tornier, Inc. is recalling five Stryker Latitude EV Humeral Revision Stem Trials (150mm) because they were laser-marked with the wrong size and side information. Components marked as "Large / Right" with a yellow color indicator are actually "Medium / Left" size with a red indicator. This error could cause surgical teams to use incorrect tools while preparing for an elbow replacement, though no injuries have been reported to date.
The mismatch between the marking on the tool and its actual size could lead to incorrect bone preparation or the selection of the wrong permanent implant during surgery. This may result in surgical delays or the need for a follow-up revision surgery to correct the implant.
The device is marked with Reference 9030103 but physically corresponds to Reference 9030092.
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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