Mako Surgical Corporation: Medical Device Recall in 2016 - (Recall #: Z-1588-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

MAKOplasty Hip Array Kit Laminate 150230

Product Classification:

Class II

Date Initiated: November 25, 2015

Date Posted: May 11, 2016

Recall Number: Z-1588-2016

Event ID: 73199

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.

Status: Terminated

Product Quantity: 10 units.

Code Information:

Catalog No. 210540, Lot Code: 150324

Distribution Pattern:

CO, KY, MN, WA and WV

Voluntary or Mandated:

Voluntary: Firm initiated