Recall Z-0064-2010 ยท HAW Neurological Stereotaxic Instrument
Mako Surgical Corporation
200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labe
| Date | Oct 19, 2009 (initiated Jul 17, 2009) |
| Status | Terminated |
| Reason | Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub components of the 20300 Rio Standard System. |
| Root cause | Device Design |
| Action | A Recall Notice, dated July 15, 2009, was sent to owners of the RIO system (hospital OR staff) with a signed acknowledgement returned to MAKO. Surgeons using the RIO system during the recall time period, regardless of whether their system has already been upgraded, are given the notification letter and asked to sign and return the acknowledgement memo. The letter stated that customers' RIO will be upgraded to replace the potentially faulty cable with a new cable. Their MAKOplasty Specialist (MPS) will notify them when their system was scheduled to have their fiber optic cable upgrade. The |
| Quantity | 23 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 Mako Surgical Corp., Nov 25, 2008 |