Phantom TTC Nail, 10.0 X 200mm, Right
Recall
- Recall Number
- Z-1254-2024
- Event Number
- 93900
- Firm
- Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062
- FEI Number
- 3008650117
- Product Code
- HSB
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 21, 2023
- Posted
- March 5, 2024
Description
Phantom TTC Nail, 10.0 X 200mm, Right
Medical devices distributed, prior to sterilization
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.
US:CA OUS: None