FDA Device recall Z-1868-2017
SmartTools Knee System Orthopedic Stereotaxic Instrument
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of SmartTools Knee System Orthopedic Stereotaxic Instrument by Orthosoft, citing there has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1868-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-20 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthosoft |
| Distribution | US |
Product
SmartTools Knee System Orthopedic Stereotaxic Instrument
Reason
There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
Identifiers
| code_info | Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711 |
|---|
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-1868-2017%22
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