FDA Medical Device Recalls (openFDA)
Mako Surgical Corporation: MAKOplasty Hip Array Kit Laminate 150230
- Recall number
- Z-1588-2016
- Recalling firm
- Mako Surgical Corporation
- Product
- MAKOplasty Hip Array Kit Laminate 150230
- Status
- Terminated
- Initiated
- 2015-11-25
- Posted
- not on file
- Terminated
- 2016-08-25
- 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.
- 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
- 10 units.
- Distribution
- CO, KY, MN, WA and WV
- Lot, serial or model codes
- Catalog No. 210540, Lot Code: 150324
- 510(k) numbers
- ["K121064"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3005985723
- Firm city
- Plantation
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28