CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
P28 Phanton Intramedullary Nail System recalled by Paragon 28
Paragon 28 is recalling P28 Phanton Intramedullary Nail System, Phantom Hindfoot Ttc/TC Ball Tipped Guide Rod, distributed nationwide in the US. The recall was initiated on 17 Jun 2026 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-2758-2026
- FDA event ID
- 99276
- Recalling firm
- Paragon 28, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2026
- FDA classified
- 17 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Masks, Gloves & PPE
Timeline
| 17 Jun 2026 | Recall initiated by company | |
| 17 Jul 2026 | Classified by FDA | +30 days |
| 29 Jul 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
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
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Where it was distributed
US nationwide, Australia, Canada, The Netherlands, and New Zealand
Questions about this recall
Is P28 Phanton Intramedullary Nail System, Phantom Hindfoot Ttc/TC Ball Tipped Guide Rod recalled?
Yes. Paragon 28 recalled P28 Phanton Intramedullary Nail System, Phantom Hindfoot Ttc/TC Ball Tipped Guide Rod on 17 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2758-2026.
Why was it recalled?
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Which lots are affected?
UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
Where was it sold?
US nationwide, Australia, Canada, The Netherlands, and New Zealand
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 Paragon 28
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev recalled | Paragon 28 | Other | Nationwide |
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Small Right Rev recalled | Paragon 28 | Other | 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, 0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA |
| Device | CLASS II | Phantom TTC Nail, TTC Nail, 0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA |
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|---|---|---|---|---|---|
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&m Halyard | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: PPE KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |