K2M Fenestrated Tap Adapter Recalled for Mislabeled Packaging
K2M, Inc. is recalling 462 Fenestrated Tap Adapters because the products are mislabeled. The devices are used for bone biopsies and vertebral body augmentation.
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, and the source text identifies the issue as mislabeling without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
K2M, Inc. is recalling 462 units of the Fenestrated Tap Adapter (REF# 5001-90011). The recall was initiated because the products are mislabeled. The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove bone tissue samples from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the surgical site. It is also intended to dispense cement for vertebral body augmentation using a vertebroplasty procedure.
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 facilities that have received these products should stop using them and contact K2M, Inc. for further instructions regarding the return or disposal of the mislabeled devices.
The recalled product
- Product
- Fenestrated Tap Adapter (REF# 5001-90011) 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 technique, as well as to provide and mai
- Manufacturer
- K2M, Inc
- 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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