Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise
Stryker Leibinger 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, but the source text describes a potential packaging compromise without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling QUIKFLAP 3 X 2-Hole Dog Bone Plates with 1.5x4mm Self Tapping Screws, Part Number 12-01531S, intended for use on the cranium. The recall involves 22,831 units of the medical device.
The recall is issued 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.
The affected products were distributed in the United States (Arizona, Florida, New Hampshire, and Ohio), Australia, Canada, France, New Zealand, and the United Kingdom. Healthcare providers and facilities should check their inventory for these specific part numbers and codes (1000181748, 1000295062) and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, 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 (2)
- 1000181748
- 1000295062
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.
See all 18 products in this recall →Related recalls
Same manufacturer · Stryker Leibinger GmbH & Co. KG
See all →- HighScopis ENT Navigation Software Contains Visual Guidance Alignment Error
FDA (Devices) · 2024-05-29
- ModerateStryker Dynamic Mesh Mislabeled with Incorrect Catalog Number
FDA (Devices) · 2024-05-15
- HighTMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval
FDA (Devices) · 2023-03-15
- HighStryker medical implant recalled for manufacturing defect in barrier layer
FDA (Devices) · 2022-03-09
- ModerateStryker DirectInject Bone Cement Recalled Due to Injection Failure
FDA (Devices) · 2021-04-28
Same hazard · sterile barrier compromise
See all →- HighBARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- ModerateDisposable Mixing Bowls with Spatula recalled for compromised sterile barrier
FDA (Devices) · 2026-05-06
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21
- HighIntroducer Needle REF NDL-107-04 Sterile Packaging Recall
FDA (Devices) · 2025-05-14
- HighGalt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue
FDA (Devices) · 2025-05-14
Similar recalls
- HighBiomet Recalls Sterile Trac System Thinflap Burr Hole Plates
FDA (Devices) · 2020-12-23
- SevereStryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
FDA (Devices) · 2020-11-18
- HighStryker Locking Screw Recall Due to Compromised Sterility
FDA (Devices) · 2020-06-24
- HighStryker Locking Screw Recall Due to Potential Sterility Compromise
FDA (Devices) · 2020-06-24
- HighStryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity
FDA (Devices) · 2020-06-24
- ModerateStryker Recalls Sagittal Blades Due to Potential Sterile Barrier Breach
FDA (Devices) · 2016-10-26