Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise
Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential sterile barrier compromise after a specific time period, which is a precautionary measure without reported injuries or illnesses in the source text.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling QUIKFLAP, 3 X 2-Hole Dog Bone Plates with 1.5x4mm Self Drilling Screws (Part Number 12-01530S). These medical devices are intended for use on the cranium. The recall involves 22,831 units distributed in the United States (AZ, FL, NH, OH), Australia, Canada, France, New Zealand, and the UK.
The recall is being conducted because there is a potential for the external packaging, which serves as the sterile barrier, to become compromised after a three-year term. This compromise could affect the sterility of the device.
Healthcare providers and facilities should stop using the affected devices and contact Stryker for instructions on return or replacement. Patients who have already received these implants should contact their healthcare provider if they have concerns.
The recalled product
- Product
- QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Hazard
- Affected units
- 22,831
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1000107793
- 1000107794
- 1000107795
- 1000111407
- 1000113293
- 1000119681
- 1000119682
- 1000124116
- 1000130031
- 1000134145
- 1000139203
- 1000141585
- 1000148808
- 1000150571
- 1000156031
- 1000159892
- 1000166365
- 1000168534
- 1000169198
- 1000170705
Distribution
Part of a larger recall action
This product is one of 18 recalled by Stryker Leibinger GmbH & Co. KG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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