Drug recall
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector)…
FDA recall event 72224 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 72224 |
|---|---|
| Recall numbers | Z-0224-2016 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. |
| Initiation date | Jul 16, 2015 |
| Report date | Nov 11, 2015 |
| Termination date | Dec 14, 2016 |
| City | Plantation |
| State | FL |
| Country | United States |
| FEI number | 3005985723 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: