Product Wiki · Recalls · Health Canada — Medical Devices

PERFORATOR BIT - CRANIUM (2020-10-20) — recall 61804

Health Canada — Medical Devices · Canada · 2020-11-06 · 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: 61804
Date of alert: 2020-11-06
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: During visual inspection during the manufacturing process a visual defect was observed. Following an internal investigation between Stryker and the 3rd party supplier, there is a potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/perforator-bit-cranium-2020-10

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.

PERFORATOR BIT - CRANIUM (2020-10-20) — recall 61804

Related