Health product recall

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