Recall Z-1492-2019
K2M, Inc · initiated April 18, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Codes / lots: All lots in distribution
Reason for recall
The products are mislabeled.
FDA-determined cause: Under Investigation by firm
Action taken
Urgent Medical Device Recall notification letters dated 4/18/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact the Regulatory Compliance Team: Spine-RegulatoryActions@Stryker.com or 201.749.8090.
Details
- Recall number
- Z-1492-2019
- Initiated
- April 18, 2019
- Terminated
- June 19, 2020
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 462 total
- Distribution
- The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
- Recalling firm
- K2M, Inc, Leesburg, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1491-2019 Class II | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product…The products are mislabeled. | 04/18/2019Terminated |