Recall Z-0959-2017 ยท OLO Orthopedic Stereotaxic Instrument
Brainlab AG
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
| Date | Oct 27, 2016 |
| Status | Terminated |
| Reason | Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing |
| Root cause | Mixed-up of materials/components |
| Action | The firm sent out a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter via e-mail to all affected customers describing the reason for the recall as well as actions that needed to be taken. User Corrective Action: Affected customers are asked to identify all Femoral and Tibial Cutting Block Adapter Bases with serial numbers ranging from 1267114001 1267114070 and with serial number 1308615032, and remove them from clinical use in your hospital. Affected customers are not required to return the affected devices to Brainlab. Instead they are asked to dispose them according to their local regul |
| Quantity | 29 units |
| Distribution | US Consignees located in the following states: New York, Wisconsin, Oklahoma and District of Columbia.***Foreign Conisgnees located in the following countries: Australia; Belarus; Germany; India; Japan; Malaysia; Singapore; Switzerland; United Arab Emirates and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102990 | BRAINLAB KNEE Brainlab AG, Apr 4, 2011 |