Stryker Corporation is recalling 5,864 units of the MOLLI 2 System, including markers, introducers, tablets, and specialized surgical pens. The recall was initiated because magnetized surgical tools used during tissue removal procedures can accidentally dislodge the markers from their intended locations. This issue requires an update to the product's labeling and Instructions for Use to ensure healthcare providers are aware of the risk during surgery.
If the magnetized surgical tools cause a marker to move or dislodge, it can lead to inaccurate targeting during tissue removal. This poses a risk of surgical delays, incomplete removal of target tissue, or damage to surrounding healthy tissue.
Product labeling and Instructions for Use (IFU) update.
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal.
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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