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