CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
Medtronic Adapter Percutaneous Pin recalled by Medtronic Navigation
Medtronic Navigation is recalling Medtronic Adapter Percutaneous Pin, distributed nationwide in the US. The recall was initiated on 6 Dec 2018 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-0707-2020
- FDA event ID
- 84045
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2018
- FDA classified
- 19 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Dec 2018 | Recall initiated by company | |
| 19 Dec 2019 | Classified by FDA | +378 days |
| 25 Dec 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.
Product as listed by the FDA
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.
Where it was distributed
Distribution was nationwide. There was government/military/foreign distribution.
Questions about this recall
Why was it recalled?
Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.
Which lots are affected?
Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.
Where was it sold?
Distribution was nationwide. There was government/military/foreign 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 26 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
All 92| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation | Medtronic Navigation | Other | Nationwide |
| Device | CLASS II | StealthStation S8 App versions 1.3.0 and 1.3.2 recalled | Medtronic Navigation | Device Malfunction | Nationwide |
| Device | CLASS I | Stealth S8 Clinical recalled by Medtronic Navigation | Medtronic Navigation | Device Malfunction | Nationwide |
| Device | CLASS II | Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled | Medtronic Navigation | Other | Nationwide |
| Device | CLASS II | Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled | Medtronic Navigation | Other | Nationwide |
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