FDA Device

MAKOplasty Hip Array Kit Laminate 150230

Hazard

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.

What You Should Do

Remedy

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.

Products

MAKOplasty Hip Array Kit Laminate 150230
Brand
Mako Surgical Corporation
UPC
Catalog No. 210540, Lot Code: 150324

Units Affected

10 units.