CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report
Medtronic Navigation O-arm O2 Surgical Imaging System Product recalled
Medtronic Navigation, Inc.-Littleton is recalling Medtronic Navigation O-arm O2 Surgical Imaging System Product, distributed nationwide in the US. The recall was initiated on 22 Sep 2016 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-0070-2017
- FDA event ID
- 75279
- Recalling firm
- Medtronic Navigation, Inc.-Littleton, Littleton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2016
- FDA classified
- 11 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 22 Sep 2016 | Recall initiated by company | |
| 11 Oct 2016 | Classified by FDA | +19 days |
| 19 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Product as listed by the FDA
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
Where it was distributed
Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
Questions about this recall
Is Medtronic Navigation O-arm O2 Surgical Imaging System Product recalled?
Yes. Medtronic Navigation, Inc.-Littleton recalled Medtronic Navigation O-arm O2 Surgical Imaging System Product on 22 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0070-2017.
Why was it recalled?
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Which lots are affected?
Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930 C0981 C0986 C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074
Where was it sold?
Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
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 Medtronic Navigation, Inc.-Littleton
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | O-arm O2 Imaging System-Mobile x-ray system designed recalled | Medtronic Navigation, Inc.-Littleton | Device Malfunction | Nationwide |
| Device | CLASS II | The O-arm O2 Imaging System is a mobile x-ray system recalled | Medtronic Navigation, Inc.-Littleton | Other | Nationwide |
| Device | CLASS II | O-arm" O2 Imaging System, Product Number/CFN: BI recalled | Medtronic Navigation, Inc.-Littleton | Other | 23 states |
| Device | CLASS II | Medtronic 0-arm TM 1000 Imaging Systems recalled by Medtronic Navigation | Medtronic Navigation, Inc.-Littleton | Other | Nationwide |
| Device | CLASS II | Medtronic Navigation 0-arm 02 Imaging System interventional recalled | Medtronic Navigation, Inc.-Littleton | Device Malfunction | Nationwide |
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 |