CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled
Medtronic Navigation is recalling Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous, distributed nationwide in the US. The recall was initiated on 28 Nov 2023 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-0698-2024
- FDA event ID
- 93611
- Recalling firm
- Medtronic Navigation, Lafayette, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Nov 2023
- FDA classified
- 10 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Nov 2023 | Recall initiated by company | |
| 10 Jan 2024 | Classified by FDA | +43 days |
| 17 Jan 2024 | 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
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
Product as listed by the FDA
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Where it was distributed
Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerland, United Kingdom.
Questions about this recall
Why was it recalled?
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
Which lots are affected?
UDI: 00613994247872/ Serial Numbers: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, 2023060369
Where was it sold?
Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerland, United Kingdom.
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.
Other products in this recall event
1 other product · FDA event 93611| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled | Medtronic Navigation | Other | Nationwide |
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 I | StealthStation S8 Application recalled by Medtronic Navigation | Medtronic Navigation | Device Malfunction | Nationwide |
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