Recall Z-1255-2024
Paragon 28, Inc. · initiated December 21, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Codes / lots: PA23005922
Reason for recall
Medical devices distributed, prior to sterilization
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1255-2024
- Initiated
- December 21, 2023
- Posted by FDA
- March 5, 2024
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 1
- Distribution
- US:CA OUS: None
- Recalling firm
- Paragon 28, Inc., Englewood, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1254-2024 Class II | Phantom TTC Nail, 10.0 X 200mm, RightMedical devices distributed, prior to sterilization | 12/21/2023Open, Classified |
| Z-1256-2024 Class II | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RMedical devices distributed, prior to sterilization | 12/21/2023Open, Classified |