PlainRecalls
FDA Devices Moderate Class II Terminated

MAKOplasty Hip Array Kit Laminate 150230

Reported: May 11, 2016 Initiated: November 25, 2015 #Z-1588-2016

Product Description

MAKOplasty Hip Array Kit Laminate 150230

Reason for Recall

Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

Details

Recalling Firm
Mako Surgical Corporation
Units Affected
10 units.
Distribution
CO, KY, MN, WA and WV
Location
Plantation, FL

Frequently Asked Questions

What product was recalled?
MAKOplasty Hip Array Kit Laminate 150230. Recalled by Mako Surgical Corporation. Units affected: 10 units..
Why was this product recalled?
Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 11, 2016. Severity: Moderate. Recall number: Z-1588-2016.