Stryker Restoris RIO Reamer Handle — Class II medical device recall Z-1193-2017
Terminated recall by Mako Surgical Corporation, reported 2017-02-22, distributed nationwide. Failure of the Offset Cup Reamer Handle not engaging its mating components.
| Recall number | Z-1193-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2017-02-10 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2019-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, DE, HK, IT, SG, TH, ZA |
| Quantity | 595 units |
| Model numbers | 207080 |
Product
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Reason for recall
Failure of the Offset Cup Reamer Handle not engaging its mating components.
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-1193-2017. 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.