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Recall Observatory FDA recall evidence

Device product

MAKOplasty Hip Array Kit Laminate 150230

Z-1588-2016

November 25, 2015

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 73199
Status
Terminated
Classification
Class II
Quantity
10 units.
Official record key
device-enforcement:Z-1588-2016

Official wording

Reason: 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.

Code information: Catalog No. 210540, Lot Code: 150324

Distribution pattern: CO, KY, MN, WA and WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.