Class 2 Device Recall Phantom Hindfoot TTC/TC Nail System

• Date Initiated by Firm: July 30, 2021
• Create Date: September 17, 2021
• Recall Status: Terminated on December 15, 2021
• Recall Number: Z-2488-2021
• Recall Event ID: 88553
• Product Classification: Bit, drill - Product Code HTW
• Product: Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection; ; p28 P99-110-4630
• Code Information: Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550
• Recalling Firm/ Manufacturer: Paragon 28, Inc.; 14445 Grasslands Dr; Englewood CO 80112-7062
• For Additional Information Contact: Mandy Kinnee; 888-728-1888
• Manufacturer Reason for Recall: A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
• FDA Determined Cause: Process change control
• Action: On 08/12/2021, the Recalling Firm emailed to its distributors an "Medical Device Recall" Notification Letter inform them that it was identified that there is a thin wall condition between the inner cannulation and the flutes of the drill. At worst case, the defect is a fracture through the wall of the drill to the cannulation beneath. This feature is potentially nonconforming in some units within the lot identified below. The distributor was instructed to: 1) Immediately check its inventory and hospitals/health care facility within their region and to identify, discontinue use, quarantine and not distribute any further the affected products. 2) Complete the Medical Device Recall Response Form and return to mkinnee@paragon28.com. The form is to be completed and returned even if no physical product is in their possession. 3) Immediately return affected devices along with a copy of the Medical Device Recall Response Form to the Recalling Firm at Paragon28, Attn: Recalls, RN-008, 14445 Grasslands Dr., Englewood, CO 80112. For questions or further assistance - contact the Recalling Firm at: email - mkinnee@paragon28.com or complaints@paragon28.com Phone - 949-280-7688
• Quantity in Commerce: 14 drill bits
• Distribution: U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.