Recall Z-1491-2019 ยท KNW Instrument, Biopsy
K2M, Inc
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 technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenest
| Date | Apr 18, 2019 |
| Status | Terminated |
| Reason | The products are mislabeled. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 462 total |
| Distribution | The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152872 | K2M Fenestrated Tap System K2m, Jan 5, 2016 |