FDA-Device2026-07-29Class IIPACKAGING DEFECT
Paragon 28 Phantom Hindfoot Guide Rod recalled for sterile packaging breach
What this means
Paragon 28 received two complaints about breaches in the sterile barrier packaging of specific lots of the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (0.30 mm, 800 mm). The packaging breach could potentially allow contamination of the surgical device before use. No injuries have been reported.
- Check the lot number on your Paragon 28 guide rod packaging (five lot numbers affected: 501167202225, 501167302225, 501209514725, 501259627925, 501275832225).
- If you have an affected unit, do not use it and contact your supplier or Paragon 28 immediately.
- Return the device for a replacement or credit.
The agency's original wording
Hazard
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Intended for
Adults
Illnesses reported
None reported
Sold states
US nationwide, Australia, Canada, The Netherlands, and New Zealand
Affected count
514 units
Manufactured in
14445 Grasslands Dr, N/A, Englewood, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2758-2026Want us to check the next one for you?
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