Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062 Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Brand
Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062
Lot Codes / Batch Numbers
PA23005922
Products Sold
PA23005922
Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062 is recalling Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L due to Medical devices distributed, prior to sterilization. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medical devices distributed, prior to sterilization
Recommended Action
Per FDA guidance
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 Orders@paragon28.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026