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SCHANZ SCREW SELF DRILL (2017-09-19)
- Starting date:
- September 19, 2017
- Posting date:
- October 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-64752
Affected products
SCHANZ SCREW SELF DRILL
Reason
The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the product's sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.
Affected products
SCHANZ SCREW SELF DRILL
Lot or serial number
1723305
Model or catalog number
20070057
Companies
- Manufacturer
-
Microport Orthopedics Ltd.
5677 Airline Road
Arlington
38002
Texas
UNITED STATES