P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod recall
Paragon 28, Inc. recalled P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod on July 29, 2026 because of paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. It was sold nationwide.
Why it was recalled
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
What's recalled
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.
Quantity: 514 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Paragon 28, Inc., Englewood, CO
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US nationwide, Australia, Canada, The Netherlands, and New Zealand - Status
- Ongoing
- Recall number
- Z-2758-2026
- Source
- U.S. Food and Drug Administration
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