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U.S. Department of Health and Human Services

Class 2 Device Recall Phantom TTC Nail

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  Class 2 Device Recall Phantom TTC Nail see related information
Date Initiated by Firm December 21, 2023
Date Posted March 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-1255-2024
Recall Event ID 93900
510(K)Number K210869  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Code Information PA23005922
Recalling Firm/
Manufacturer		 Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact Mandy Mahistadt
888-728-1888
Manufacturer Reason
for Recall		 Medical devices distributed, prior to sterilization
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 1
Distribution US:CA OUS: None
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = Paragon 28, Inc.
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