CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Phantom TTC Nail, TTC Nail, 11.5, Right recalled by Paragon 28
Paragon 28 is recalling Phantom TTC Nail, TTC Nail, 11.5, Right, distributed in California. The recall was initiated on 21 Dec 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-1256-2024
- FDA event ID
- 93900
- Recalling firm
- Paragon 28, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 5 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 5 Mar 2024 | Classified by FDA | +75 days |
| 13 Mar 2024 | 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
Medical devices distributed, prior to sterilization
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Where it was distributed
US:CA OUS: None
Questions about this recall
Why was it recalled?
Medical devices distributed, prior to sterilization
Which lots are affected?
PA23006856
Where was it sold?
US:CA OUS: None
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
2 other products · FDA event 93900| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Phantom TTC Nail, TTC Nail, 10.0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA | |
| CLASS II | Phantom TTC Nail, 10.0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA |
More recalls from Paragon 28
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Nominal Right recalled | Paragon 28 | Other | Nationwide |
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Small Right recalled | Paragon 28 | Other | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Phantom Fibula Nail, Right, Ti, Fibula Nail recalled by Paragon 28 | Paragon 28 | Potency & Assay | Nationwide |
| Device | CLASS II | Phantom TTC Nail, 10.0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA |
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| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |