| | Class 2 Device Recall Phantom TTC Nail |  |
| Date Initiated by Firm | December 21, 2023 |
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| Date Posted | March 05, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1254-2024 |
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| Recall Event ID |
93900 |
| 510(K)Number | K210869 |
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| Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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| Product | Phantom TTC Nail, 10.0 X 200mm, Right |
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| Code Information |
PA23005925 |
Recalling Firm/
Manufacturer |
Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062
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| For Additional Information Contact | Mandy Mahistadt
888-728-1888 |
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Manufacturer Reason
for Recall | Medical devices distributed, prior to sterilization |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Distribution | US:CA
OUS: None |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HSB
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