Approximately 90 Zimmer Comprehensive Shoulder Stem, Comprehensive Micro Stem, and Comprehensive Mini Stem implants in the United States are being recalled. These shoulder prostheses may have excess manufacturing material remaining within the taper, which can prevent a surgeon from properly connecting or removing the inserter tool during surgery. There have been five reports of surgeons encountering this connection issue, which can lead to a significant extension of surgery time while a replacement implant is located. Consumers should contact their healthcare provider for more information about their specific implant.
The presence of excess material in the implant taper can interfere with the surgical tools required to place the device. This defect may lead to clinically significant extensions of surgery time while the patient is under anesthesia, increasing the risk of surgical complications.
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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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.