FDA-Device2020-03-18Class II
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.
Nextremity Solutions
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
Sold states
International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Affected count
190 units
Manufactured in
6210 N Buffalo St, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2020Don't want to check this manually?
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