Recall Z-1849-2019 ยท HRX Arthroscope
Stryker GmbH
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
| Date | Apr 30, 2019 |
| Status | Terminated |
| Reason | The seal integrity of the sterile bag containing the kits may be compromised. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers. |
| Quantity | 1600 |
| Distribution | The products were distributed US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922391 | ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS Instratek, Inc., Aug 18, 1992 |