The Zimmer BiometCPT hip system should be used only if no alternatives are available and patients have been warned of potential risks, the US Food and Drug Administration said in a 17 September safety alert.
Zimmer Biomet CPT Hip Tied To Fracture Risk
The US FDA is advising against use of the Zimmer Biomet CPT hip implant after research indicated it may pose a higher risk of thigh bone fracture than similar products.
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International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
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A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.
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A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
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Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.
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The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.