Health product recall

Mako Guidance Module (2019-06-11)

Starting date:
June 11, 2019
Posting date:
July 5, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70359

Last updated: 2019-07-05

Affected Products

Mako Guidance Module

Reason

Stryker has discovered that the audio volume of the Mako System is unable to be adjusted in certain guidance modules.

Affected products

Mako Guidance Module

Lot or serial number

GUD807

Model or catalog number

207110

Companies
Manufacturer
MAKO SURGICAL CORP.
2555 DAVIE ROAD
FT. LAUDERDALE
33317
Florida
UNITED STATES