QuickFlip 3 - 2-Hole Plate Set, 2-Hole Plate/Burr Hole Cover, and Burr Hole Cover Set, Universal Neuro III - 2-Hole Plate Set, Self-Drilling Screw, 2-Hole Plate Set, With Tab, and Burr Hole Cover, Self-Drilling Screw (2018-05-14)
- Starting date:
- May 14, 2018
- Posting date:
- June 1, 2018
- 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-66932
Affected products
A. QuickFlip 3 - 2-Hole Plate Set
B. QuickFlip 3 - 2-Hole Plate/Burr Hole Cover
C. QuickFlip 3 - Burr Hole Cover Set
D. Universal Neuro III 2-Hole Plate Set, Self-Drilling Screw
E. Universal Neuro III 2-Hole Plate Set, With Tab
F. Universal Neuro III Burr Hole Cover, Self-Drilling Screw
Reason
Stryker has become aware that the current packaging and Information for Use (IFU) indicate a five year shelf life. During long-term product testing, it was discovered that after a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Such compromised packaging results in the loss of the vacuum seal allowing for contamination of the inside peel pouch. A breach of the outer peel pouch has only been observed with packages at shelf life end and after excessive transportation testing.
Affected products
A. QuickFlip 3 - 2-Hole Plate Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
12-01532S
Companies
- Manufacturer
-
Stryker Leibinger Gmbh & Co. Kg
Botzinger Strasse 41
Freiburg
79111
GERMANY
B. QuickFlip 3 - 2-Hole Plate/Burr Hole Cover
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
12-01536S
Companies
- Manufacturer
-
Stryker Leibinger Gmbh & Co. Kg
Botzinger Strasse 41
Freiburg
79111
GERMANY
C. QuickFlip 3 - Burr Hole Cover Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
12-01538S
Companies
- Manufacturer
-
Stryker Leibinger Gmbh & Co. Kg
Botzinger Strasse 41
Freiburg
79111
GERMANY
D. Universal Neuro III 2-Hole Plate Set, Self-Drilling Screw
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
12-01540S
Companies
- Manufacturer
-
Stryker Leibinger Gmbh & Co. Kg
Botzinger Strasse 41
Freiburg
79111
GERMANY
E. Universal Neuro III 2-Hole Plate Set, With Tab
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
12-01542S
Companies
- Manufacturer
-
Stryker Leibinger Gmbh & Co. Kg
Botzinger Strasse 41
Freiburg
79111
GERMANY
F. Universal Neuro III Burr Hole Cover, Self-Drilling Screw
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
12-01548S
Companies
- Manufacturer
-
Stryker Leibinger Gmbh & Co. Kg
Botzinger Strasse 41
Freiburg
79111
GERMANY