Device product
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.
Z-1458-2020
Product summary
- Event
- Event 84924
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 units
- Official record key
device-enforcement:Z-1458-2020
Official wording
Reason: 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
Code information: Lot Number: 168117318B UDI: 00817701020011
Distribution pattern: International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Derived failure modes
-
Unknown
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