Phantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential compromise of sterility, which is a low-to-moderate risk contamination issue.
Plain-English summary
Paragon 28, Inc. is recalling certain units of the P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, specifically the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (Size: 0.30 mm, Length: 800 mm; Item number P31-955-1800-S). The recall was initiated after the company received two complaints involving breaches in the sterile barrier of the pouch packaging.
The affected products were distributed in the United States, Australia, Canada, the Netherlands, and New Zealand. A total of 514 units are involved across several lot numbers.
Healthcare providers and facilities should check their inventory for the affected lot numbers and follow appropriate protocols for handling potentially compromised sterile medical devices.
The recalled product
- 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.
- Manufacturer
- Paragon 28, Inc.
- Affected units
- 514
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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.
Distribution
Distributed nationwide across the United States.
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