FDAClass IIMay 11, 2016

MAKOplasty Hip Array Kit Laminate 150230 recall

MAKOplasty Hip Array Kit Laminate 150230

Why was MAKOplasty Hip Array Kit Laminate 150230 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog No. 210540, Lot Code: 150324

Product
MAKOplasty Hip Array Kit Laminate 150230
Recalling firm
Mako Surgical Corporation
Quantity
10 units.
Distribution
CO, KY, MN, WA and WV
Recall date
May 11, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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