QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Reported: September 5, 2018 Initiated: June 22, 2018 #Z-2898-2018
Product Description
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Reason for Recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Details
- Recalling Firm
- Stryker Leibinger GmbH & Co. KG
- Units Affected
- 22,831 total
- Distribution
- US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
- Location
- Freiburg Im Breisgau, N/A
Frequently Asked Questions
What product was recalled? ▼
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).. Recalled by Stryker Leibinger GmbH & Co. KG. Units affected: 22,831 total.
Why was this product recalled? ▼
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2898-2018.
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