CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report
Quikflap, -hole Dog Bone Plates With 1.5x4mm Self Drilling Screws recalled
Stryker Leibinger GmbH & Co. KG is recalling Quikflap, -hole Dog Bone Plates With 1.5x4mm 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
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-2898-2018
- 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 12-01520S 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).
Where it was distributed
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Questions about this recall
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?
1000085083, 1000089303, 1000089990, 1000095193, 1000100539, 1000104523, 1000107792, 1000110518, 1000116215, 1000124115, 1000129492, 1000134144, 1000139985, 1000146194, 1000151496, 1000156358, 1000164801, 1000167015, 1000170704, 1000174837, 1000178195, 1000181123, 1000183608, 1000188543, 1000192851, 1000197301, 1000209029, 1000219395, 1000221066, 1000237512, 1000239649, 1000240995, 1000251376, 1000259411, 1000275865, 1000286361, 1000290245
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 80371This product is part of a recall event; the main page for the event is Axs Pp, -hole Dog Bone Plates With 1.5x4mm Self Drilling Screws recalled.
More recalls from Stryker Leibinger GmbH & Co. KG
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 8000-021-002, Scopis¿ ENT recalled by Stryker Leibinger GmbH & Co. | Stryker Leibinger GmbH & Co. KG | Device Malfunction | Nationwide |
| Device | CLASS II | Stryker Dynamic Mesh- Std-medium-Intended recalled | Stryker Leibinger GmbH & Co. KG | Labeling Errors | Nationwide |
| Device | CLASS II | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis recalled | Stryker Leibinger GmbH & Co. KG | Other | MA |
| Device | CLASS II | Medpor Titan OFW - MTB - Right recalled by Stryker Leibinger GmbH & Co. | Stryker Leibinger GmbH & Co. KG | Packaging Defects | Nationwide |
| Device | CLASS II | DirectInject consists of a sterile dual paste system recalled | Stryker Leibinger GmbH & Co. KG | Other | Nationwide |
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