FDAFDA · Food and drugs·Recall number Z-1458-2020
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Published March 18, 2020 · Recall initiated: February 12, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nextremity Solutions
- Distributor
- International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
- Lot
- Lot Number: 168117318B UDI: 00817701020011
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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