Recall Z-2232-2011 ยท KQM Camera, Surgical And Accessories
Mako Surgical Corporation
MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A
| Date | May 20, 2011 (initiated Oct 25, 2010) |
| Status | Terminated |
| Reason | MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO Robotic Arm Interactive Orthopedic System with SSN P7-03127, on November 22, 2010. This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. The recall was initiated after the camera manufacture, NDI, Waterloo, On |
| Root cause | Nonconforming Material/Component |
| Action | The firm, MAKO, sent a "RECALL NOTICE" letter dated November 22, 2010, to its customer. The letter described the product, problem and action to be taken. The customer was instructed to complete and return the attached Acknowledgement Form to their MAKOplasty Specialist (MPS) via mail to: MAKO Surgical Corp., Attn: Jim Pomeroy, 2555 Davie Road, Fort Lauderdale, FL 33317. The letter stated that "It is important that the camera be replaced immediately, and MAKO is currently addressing the situation with the camera manufacturer." In addition, MAKO will replace the camera with a camera that is not |
| Quantity | 1 |
| Distribution | Nationwide distribution: NY only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.