Health Canada — Medical Devices · Canada · 2017-09-08 · 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 →
Archived by the issuing authority — kept for reference
Reported risk: It appears that breakage of the instrument occurs when bending, impaction or excessive torsinal forces are applied on the instrument. The recalled lot numbers were previously reworked and they appear to be more susceptible to breakage considering that residual stresses may have been generated during the rework.
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.