Health Canada — Medical Devices · Canada · 2023-05-25 · Type II
🏛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: During an update of data used in a library shipped with Exoplan or made available on the download portal of Exocad, it was found that the use of a specific combination of an implant, sleeve and drill in a surgical kit can result in a hole being drilled for the implant 2mm too deep. In case an implant 260-340-256 of Bicon with a 4mm diameter and 6mm length is used in a fully-guided surgery procedure using a 4mm diameter Bicon sleeve it should only be possible to select a drill with 6mm length. But erroneously uses an 8mm length drill (instead of 6mm length drill) from the surgical kit. Recall start date: April 24, 2023
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.