PERFORATOR BIT - CRANIUM (2020-10-20)

Starting date:

October 20, 2020

Posting date:

November 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74255

Last updated:
2020-11-04

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  Reason
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  Affected products

Affected Products

PERFORATOR BIT - CRANIUM

Reason

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.

Affected products