Z-1254-2024Class II

Phantom TTC Nail, 10.0 X 200mm, Right

Name: Z-1254-2024 Phantom TTC Nail, 10.0 X 200mm, Right
Creator: Paragon 28, Inc.
Published: 2023-12-21
License: https://open.fda.gov/license/

Paragon 28 / initiated 2023-12-21 / Open, Classified / root cause: sterility

FDA source

Paragon 28, Inc. began a recall of Phantom TTC Nail, 10.0 X 200mm, Right on 2023-12-21. FDA classified it as Class II and gives the reason as "Medical devices distributed, prior to sterilization". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1254-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-03-05
Recalling firm: Paragon 28
Product: Phantom TTC Nail, 10.0 X 200mm, Right
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Medical devices distributed, prior to sterilization
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On January 5, 2024, Paragon 28 requested their consignee(s) return the affected device. On February 12, 2024, Paragon 28 followed up with customers by issuing a "Urgent Medical Device Recall" Notification via email. Paragon informed consignees of the following: 1. There is no action needed from your agency as the three affected devices have been returned and quarantined at Paragon 28 headquarters. 2. The information provided to your agency from Paragon 28 Sales Support related to the sterilization of these devices was provided in error and is not to be followed as other methods for sterilization have not been verified/validated. 3. Any need for this product should be directed to [email protected]. 4. Paragon 28, Inc. is actively working on a solution to this failure under a corrective action investigation. 5. Please complete the attached Recall Response Form to acknowledge this letter.
Distribution: US:CA OUS: None
Product codes and lots: PA23005925

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1254-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1254-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-05
Z-1255-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-05
Z-1256-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-05

Product code HSB

K210869Class IIPhantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. / cleared 2021-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)