Stryker QuickFlap Sterile Procedure Pack Recalled for Packaging Compromise
Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.
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, and the hazard is a potential sterile barrier compromise without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling the 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).
The recall is being issued because there is a potential for the external packaging (sterile barrier) to become compromised after a three-year term. A compromised sterile barrier could affect the sterility of the medical device.
A total of 22,831 units are affected. Distribution includes the United States (AZ, FL, NH, and OH), Australia, Canada, France, New Zealand, and the UK. Specific lot codes are listed in the agency record. Healthcare providers and facilities should check their inventory for the affected part number and codes and contact Stryker for instructions on how to proceed.
The recalled product
- Product
- 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…
- 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)
- 1000085083
- 1000089303
- 1000089990
- 1000095193
- 1000100539
- 1000104523
- 1000107792
- 1000110518
- 1000116215
- 1000124115
- 1000129492
- 1000134144
- 1000139985
- 1000146194
- 1000151496
- 1000156358
- 1000164801
- 1000167015
- 1000170704
- 1000174837
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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