Kyphx Bone Filler Device (2017-12-08) — recall 57730
Health Canada — Medical Devices · Canada · 2018-01-08 · 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 →
Reported risk: Medtronic has discovered the directional arrow at the proximal end of the instrument may be misaligned, thus the recalled product may not correctly align with the cut-out opening on the distal end of the instrument. Using affected directional bone filler devices may result in the injected cement being placed in a direction unintended by the Surgeon.
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.