Recall Z-2793-2020 ยท OLO Orthopedic Stereotaxic Instrument
Brainlab AG
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
| Date | Jul 16, 2020 |
| Status | Terminated |
| Reason | Incorrect manufacturer calibration |
| Root cause | Process control |
| Action | 1. Refer to the appendix for the list of Brainlab Curve or Kick Navigation Systems with an affected camera installed to determine if your navigation system is affected. 2. For Cranial or ENT navigation software in combination with an affected system camera installed: Do not use the Z-touch Laser Pointer for patient registration. Use other instruments with the standard instrument pivoting method for Surface Matching or Landmark Registration, or Automatic Image Registration (AIR) if available. 3. Please continue to follow the instructions and warnings as described in the user guide. Especially r |
| Quantity | 9 unit |
| Distribution | USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183605 | Spine & Trauma Navigation Brainlab AG, Aug 29, 2019 |