FDA Device recall Z-1193-2017
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular re…
- FDA Device
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular re… by Mako Surgical, citing failure of the Offset Cup Reamer Handle not engaging its mating components.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1193-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-29 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | US |
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
Failure of the Offset Cup Reamer Handle not engaging its mating components.
Identifiers
| code_info | All lots recalled, Catalog No. 207080. |
|---|
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-1193-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.