Product Wiki · Recalls · Health Canada — Medical Devices

IVEA MODEL 500A (2017-10-11) — recall 57528

Health Canada — Medical Devices · Canada · 2017-10-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57528
Date of alert
2017-10-27
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: Rotational forces on the 16082 dowel pin during deploying or folding can cause the pin to slowly "screw" its way out of position. If the pin migrates enough to allow the brace to detach from the leg pivot fitting while a patient is ambulating with weight on the handles, the product could slump to one side. This may cause the patient to stumble.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ivea-model-500a-2017-10-11

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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.