CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report

Quikflap, -hole Dog Bone Plates With 5x4mm Self Drilling Screws recalled

Stryker Leibinger GmbH & Co. KG is recalling Quikflap, -hole Dog Bone Plates With 5x4mm Self Drilling Screws, distributed in Arizona, Florida, New Hampshire, Ohio. The recall was initiated on 22 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1000107793, 1000107794, 1000107795, 1000111407, 1000113293, 1000119681, 1000119682, 1000124116, 1000130031, 1000134145, 1000139203, 1000141585, 1000148808, 1000150571, 1000156031, 1000159892, 1000166365, 1000168534, 1000169198, 1000170705, 1000171359, 1000174838, 1000176391, 1000183609, 1000188544, 1000189237, 1000191063, 1000193586, 1000195789, 1000202429, 1000215159, 1000217674, 1000220165, 1000224225, 1000231906, 1000233773, 1000236827, 1000239654, 1000245176, 1000251377, 1000254803, 1000262514

Quantity recalled22,831 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2904-2018
FDA event ID: 80371
Recalling firm: Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, N/A
Classification: Class II
Status: Terminated
Recall initiated: 22 Jun 2018
FDA classified: 29 Aug 2018
Reported: 5 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

22 Jun 2018	Recall initiated by company
29 Aug 2018	Classified by FDA	+68 days
5 Sep 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium

Where it was distributed

US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.

Arizona Florida New Hampshire Ohio

Questions about this recall

Is Quikflap, -hole Dog Bone Plates With 5x4mm Self Drilling Screws recalled?

Yes. Stryker Leibinger GmbH & Co. KG recalled Quikflap, -hole Dog Bone Plates With 5x4mm Self Drilling Screws on 22 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2904-2018.

Why was it recalled?

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Which lots are affected?

1000107793, 1000107794, 1000107795, 1000111407, 1000113293, 1000119681, 1000119682, 1000124116, 1000130031, 1000134145, 1000139203, 1000141585, 1000148808, 1000150571, 1000156031, 1000159892, 1000166365, 1000168534, 1000169198, 1000170705, 1000171359, 1000174838, 1000176391, 1000183609, 1000188544, 1000189237, 1000191063, 1000193586, 1000195789, 1000202429, 1000215159, 1000217674, 1000220165, 1000224225, 1000231906, 1000233773, 1000236827, 1000239654, 1000245176, 1000251377, 1000254803, 1000262514

Where was it sold?

US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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28 Apr 2021Device	CLASS II	DirectInject consists of a sterile dual paste system which recalled	Stryker Leibinger GmbH & Co. KG	Sterility	Nationwide

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