Fenestrated Tap Adapter recall: Labeling Error
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…
Why was Fenestrated Tap Adapter recalled?
The products are mislabeled.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots in distribution
- 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…
- Recalling firm
- K2M, Inc
- Quantity
- 462 total
- Distribution
- The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)