Class 2 Device Recall HammerTube Implant

• Date Initiated by Firm: May 26, 2022
• Create Date: July 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1468-2022
• Recall Event ID: 90436
• 510(K)Number: K171715
• Product Classification: Pin, fixation, smooth - Product Code HTY
• Product: HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
• Code Information: Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202
• FEI Number: 3008650117
• 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: Due to Titanium plasma coating not present implant.
• FDA Determined Cause: Under Investigation by firm
• Action: On 05/26/2022, the firm communicated via email to its customers/distributors informing them that Paragon 28 has identified via customer complaints that the titanium plasma coating is missing on the HammerTube Implants. On 06/15/2022, Paragon28 communicated an updated "URGENT Medical Device Recall" letter to customer that informed them of the potential health risks involved with the affected devices such as: " The defect may cause the implant to potentially result in reduced of pull-out force creating instability at the joint which may lead to delayed or lack of healing. " The implants, with the defect, may cause potential mating interaction failure between inserter and implant. " The defect may lead to an incorrect intended implant placement; directional and or depth. Customers are instructed to: 1. Review physical inventory, discontinue use, quarantine and not to further distribute the affected devices. 2. Return affected devices immediately to: Paragon28, Attn: Recalls 14445 Grasslands Dr. Englewood, CO 80112 Any questions, contact: Mandy Kinnee Email: mkinnee@paragon28.com Phone: 720.966.8333 *Note: You may also contact complaints@paragon28.com. 1.
• Quantity in Commerce: 9 implants
• Distribution: U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
• 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 = HTY