FDAFDA · Food and drugs·Recall number Z-1468-2022
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Published August 3, 2022 · Recall initiated: May 26, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to Titanium plasma coating not present implant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Paragon 28, Inc.
- Distributor
- U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
- Lot
- Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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