FDA Device recall Z-1588-2016
MAKOplasty Hip Array Kit Laminate 150230
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of MAKOplasty Hip Array Kit Laminate 150230 by Mako Surgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1588-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-25 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | CO, KY, MN, WA, WV |
Product
MAKOplasty Hip Array Kit Laminate 150230
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.
Identifiers
| code_info | Catalog No. 210540, Lot Code: 150324 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1588-2016%22
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