Product Wiki · Recalls · Health Canada — Medical Devices

NDI DISPOSABLE REFLECTIVE MARKER SPHERE (2015-07-27) — recall 53940

Health Canada — Medical Devices · Canada · 2015-08-11 · 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 →
Agency
Health Canada — Medical Devices
Recall identifier
53940
Date of alert
2015-08-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: On April 30, 2015, NDI received a complaint from a customer reporting that a DRMS sphere fell apart while the patient's leg was being aligned with the navigation system during a total knee replacement surgery. Based on the reported complaint; NDI promptly instituted a stop ship order, and then performed a recall of the affected lot. Further investigation has identified a similar failure mode, with different root causes that have occurred at a significantly lower rate in additional lots of the product.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ndi-disposable-reflective-mark

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.

Related

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.