Health product recall

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

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

PERFORATOR BIT - CRANIUM

Lot or serial number

Multiple lots, contact manufacturer.

Model or catalog number

5100-060-001

Companies
Manufacturer

Stryker Instruments A Division of Stryker Corp. DBA Stryker Instruments

4100 East Milham Ave

Kalamazoo

49001

UNITED STATES