Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
FDA device recall Z-1255-2024 · posted 2024-03-05 · Open, Classified
Recall details
- Recalling firm
- Paragon 28, Inc.
- Reason for recall
- Medical devices distributed, prior to sterilization
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 1
- Distribution
- US:CA OUS: None
- Date initiated
- 2023-12-21
- Date posted
- 2024-03-05
- Location
- Englewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Phantom Hindfoot TTC/TC Nail System (K210869) | Paragon 28, Inc. | 2021-06-28 |