Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging 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 compromise of the sterile barrier after a specific time period, which is a precautionary labeling/packaging issue without reported injuries or illnesses in the source text.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling QUIKFLAP 1x14mm Burr Hole Covers with 1.5x4mm self-drilling screws (Part Number 12-01538S). These medical devices are used on the cranium.
The recall is issued because there is a potential for the external packaging, which serves as a sterile barrier, to become compromised after a three-year term. This could affect the sterility of the device.
The recall involves 22,831 units. Distribution includes the United States (AZ, FL, NH, OH), Australia, Canada, France, New Zealand, and the UK. Specific lot codes are listed in the official recall record. Healthcare providers should stop using these devices and contact the manufacturer for instructions.
The recalled product
- Product
- QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- 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 (18)
- 1000167017
- 1000167829
- 1000171360
- 1000172321
- 1000173866
- 1000175689
- 1000178993
- 1000187364
- 1000198471
- 1000198472
- 1000202431
- 1000205662
- 1000215879
- 1000217675
- 1000226524
- 1000233194
- 1000238414
- 1000259405
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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