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U.S. Department of Health and Human Services

Class 2 Device Recall HammerTube Implant

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  Class 2 Device Recall HammerTube Implant see related information
Date Initiated by Firm May 26, 2022
Create Date July 27, 2022
Recall Status1 Open3, 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
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 2		 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 and Original Applicant = Paragon 28
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