FDA Medical Device Recalls (openFDA)
Paragon 28, Inc.: Phantom TTC Nail, 10.0 X 200mm, Right
- Recall number
- Z-1254-2024
- Recalling firm
- Paragon 28, Inc.
- Product
- Phantom TTC Nail, 10.0 X 200mm, Right
- Status
- Open, Classified
- Initiated
- 2023-12-21
- Posted
- 2024-03-05
- Terminated
- not on file
- Reason
- Medical devices distributed, prior to sterilization
- 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 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.
- Quantity
- not on file
- Distribution
- US:CA OUS: None
- Lot, serial or model codes
- PA23005925
- 510(k) numbers
- ["K210869"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3008650117
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28