P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, I
Summary
The FDA issued a Class II for P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guid by Paragon 28, Inc.. Reason: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging..
Details
Source
Device Recall
External ID
Z-2758-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Lot/Code Info: UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
Quantity Affected: 514 units
Reason for Recall
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Distribution
US nationwide, Australia, Canada, The Netherlands, and New Zealand
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-17
Company
Englewood, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Paragon 28, Inc. has 37 FDA actions in our database, including 9 recalls and 28 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Paragon 28, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Paragon 28, Inc. have FDA actions?
Paragon 28, Inc. has 37 FDA actions in our database, including 9 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2758-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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