Recall Z-1255-2024 ยท HSB Rod, Fixation, Intramedullary And Accessories
Paragon 28, Inc.
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
| Date | Mar 5, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| 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 steriliz |
| Quantity | 1 |
| Distribution | US:CA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210869 | Phantom Hindfoot TTC/TC Nail System Paragon 28, Inc., Jun 28, 2021 |