200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hy

FDA device recall Z-0064-2010 · posted 2009-10-19 · Terminated

Recall details

Recalling firm

Mako Surgical Corporation

Reason for recall

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.

Action taken

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 upgrade will be installed by a Field Service Engineer (FSE) free of charge and the RIO will be completely tested prior to being returned to service. Customers should direct questions or concerns to their MPS, FSE, or Jim Pomeroy, who can be reached at 954-927-2044.

Root cause

Device Design

Status

Terminated

Product code

HAW

Quantity affected

23

Distribution

Nationwide Distribution

Date initiated

2009-07-17

Date posted

2009-10-19

Date terminated

2010-05-12

Location

Davie, FL

Related 510(k) clearances