CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
SmartTools Knee System Orthopedic Stereotaxic Instrument recalled
Orthosoft is recalling SmartTools Knee System Orthopedic Stereotaxic Instrument, distributed nationwide in the US. The recall was initiated on 20 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1868-2017
- FDA event ID
- 76508
- Recalling firm
- Orthosoft, Montreal, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2017
- FDA classified
- 19 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 20 Feb 2017 | Recall initiated by company | |
| 19 Apr 2017 | Classified by FDA | +58 days |
| 26 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
SmartTools Knee System Orthopedic Stereotaxic Instrument
Where it was distributed
Nationwide Distribution
Questions about this recall
Is SmartTools Knee System Orthopedic Stereotaxic Instrument recalled?
Yes. Orthosoft recalled SmartTools Knee System Orthopedic Stereotaxic Instrument on 20 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1868-2017.
Why was it recalled?
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
Which lots are affected?
Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Orthosoft
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NavitrackER Kit A: Knee recalled by Orthosoft | Orthosoft | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty recalled | Orthosoft | Device Malfunction | CA, FL |
| Device | CLASS III | Navitrack¿ System - OS Knee Universal recalled by Orthosoft | Orthosoft | Device Malfunction | 20 states |
| Device | CLASS II | Navitrack System - OS Knee Universal, Stereotaxic instrument recalled | Orthosoft | Device Malfunction | 16 states |
| Device | CLASS II | NDI P7 Position Sensor, Stereotaxic Instrument recalled by Orthosoft | Orthosoft | Device Malfunction | 8 states |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |