Recall Z-2898-2018— Stryker Leibinger GmbH & Co. KG

Name: FDA recall Z-2898-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-22

Class II · Terminated

Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2018-06-22, terminated 2019-07-08. It names one FDA 510(k) clearance: K120352. Product: 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: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised..

Recalling firm: Stryker Leibinger GmbH & Co. KG
Classification: Class II
Status: Terminated
Initiated: 2018-06-22
Terminated: 2019-07-08
Firm location: Freiburg Im Breisgau, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K120352 — STRYKER QUIKFLAP STERILE PROCEDURE PACKStryker·cleared 2012-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.