K2M Fenestrated Taps Recalled for Mislabeled Packaging
K2M, Inc. is recalling 462 Fenestrated Taps because the products are mislabeled. The devices were distributed to six US states.
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 source text identifies the issue as mislabeling without reporting any injuries, illnesses, or specific safety hazards beyond the label error itself.
Plain-English summary
K2M, Inc. is recalling 462 units of Fenestrated Taps (4.5mm, 5.5mm, and 6.5mm) because the products are mislabeled. The recall includes reference numbers 5001-90013, 5001-90014, and 5001-90015. These devices are intended for use as a standalone biopsy tool to remove bone tissue samples from vertebral bodies for diagnostic purposes, or to dispense cement for vertebral body augmentation.
The affected products were distributed to the following US states: Florida, Kentucky, Michigan, Pennsylvania, South Carolina, and West Virginia. All lots in distribution are included in this recall.
Healthcare providers and consumers should stop using these products and contact K2M, Inc. for further instructions regarding the mislabeling issue.
The recalled product
- Product
- Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration…
- Manufacturer
- K2M, Inc
- Category
- Medical Device — Biopsy Tools
- Hazard
- Affected units
- 462
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)
- All lots in distribution
Distribution
Part of a larger recall action
This product is one of 2 recalled by K2M, Inc 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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