Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Phantom Fibula Nail

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Phantom Fibula Nailsee related information
Date Initiated by FirmOctober 13, 2025
Date PostedDecember 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0871-2026
Recall Event ID 97891
510(K)NumberK234128 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductPhantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Code Information UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
FEI Number 3008650117
Recalling Firm/
Manufacturer		 Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information ContactMandy Mahlstadt
720-966-8333
Manufacturer Reason
for Recall		Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
FDA Determined
Cause 2		Device Design
ActionOn 10/13/2025, recall notices were emailed to distributors who were asked to do the following: 1) Return affected devices to the firm using return label. 2) Ensure that in instances where you have distributed this affected product, that you forward this Recall Notification to your customers. 3) Replacements are available by contacting Orders@paragon28.com Complaints can be directed to complaints@paragon28.com
Quantity in Commerce20
DistributionUS Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSB
-
-