Z-2758-2026 Class II Ongoing
FDA device recall Z-2758-2026 was initiated by Paragon 28, Inc. on June 17, 2026 and is designated Class II. Reason for recall: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. The recall status is ongoing. Affected quantity: 514 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 514 units
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.
Reason for Recall
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Distribution Pattern
US nationwide, Australia, Canada, The Netherlands, and New Zealand
Code Information
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.