Paragon 28, Inc.: Passer, Wire, Orthopedic
Recall Summary Paragon 28 is recalling a specific size and length of Phantom Intramedullary Nail System guide rods (item P31-955-1800-S) used in foot and ankle surgery due to breaks in the sterile packaging on two units. The affected product was distributed nationwide in the US as well as in Australia, Canada, The Netherlands, and New Zealand. This is a Class I recall, the most serious classification.
- Recalling firm
- Paragon 28, Inc.
- Product
- 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.
- Reason
- Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US nationwide, Australia, Canada, The Netherlands, and New Zealand
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e7834120-d6a2-48bf-a42f-33fceee5dc60