Z-1588-2016Class II

MAKOplasty Hip Array Kit Laminate 150230

Name: Z-1588-2016 MAKOplasty Hip Array Kit Laminate 150230
Creator: Mako Surgical Corporation
Published: 2015-11-25
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2015-11-25 / Terminated

FDA source

Mako Surgical Corporation began a recall of MAKOplasty Hip Array Kit Laminate 150230 on 2015-11-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1588-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2016-04-29
Terminated: 2016-08-25
Recalling firm: Mako Surgical Corp.
Product: MAKOplasty Hip Array Kit Laminate 150230
Product code: OLO Orthopedic Stereotaxic Instrument
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.
FDA root cause: Component change control
Action: On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015.
Quantity in commerce: 10 units.
Distribution: CO, KY, MN, WA and WV
Product codes and lots: Catalog No. 210540, Lot Code: 150324

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1588-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1588-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-04-29

Product code OLO

K121064Class IIMakoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation / cleared 2012-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)