MAKOplasty Hip Array Kit Laminate 150230 — Class II medical device recall Z-1588-2016
Terminated recall by Mako Surgical Corporation, reported 2016-05-11, distributed in CO, KY, MN, WA, WV. Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate
| Recall number | Z-1588-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2015-11-25 |
| Classified | 2016-04-29 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2016-08-25 |
| Distributed | CO, KY, MN, WA, WV |
| Quantity | 10 units |
| Lot numbers | 150324 |
| Model numbers | 210540 |
Product
MAKOplasty Hip Array Kit Laminate 150230
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1588-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.