Stryker QuickFlap Sterile Procedure Packs Recalled for Packaging Compromise
Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.
What this means for you
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, which is a low-risk contamination issue without reported illnesses or injuries, fitting the Moderate severity criteria.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling 22,831 units of QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S. 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).
The recall is due to a potential for the external packaging (sterile barrier) to become compromised after a three-year term. This could affect the sterility of the medical device.
The affected units were distributed in the United States (AZ, FL, NH, and OH), Australia, Canada, France, New Zealand, and the UK. Healthcare providers and facilities should check their inventory for Part Number 12-01521S and stop using the affected products.
The recalled product
- Product
- QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S 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 an
- 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 (1)
- 1000193584
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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