Health Canada — Medical Devices · Canada · 2020-12-04 · Type II
As described by Health Canada — Medical Devices: EASYCLIP AGRAFE BIPODE MONOCORTICALE & BICORTICALE SUPERELASTIQUE (2020-09-23)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: Stryker Trauma GmbH (Trauma & Extremities Division) has identified a risk of a nickel release above the acceptable Margin of Safety for EasyClip implants. This risk was proactively identified following an update of the toxicological risk assessment for the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress products July 8 2020. It was determined that pediatric patients with a body weight of less than 20 kg should have a maximum of 2 Easyclip staples implanted to remain in the acceptable Margin of Safety. Therefore, the current IFU will be updated, a contraindication will be added "Do not implant more than 2 EasyClip devices in pediatric patients ".
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