FDA-Device2022-03-16Class II
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Nextremity Solutions
Hazard
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
Sold states
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
Affected count
24 units
Manufactured in
1195 Polk Dr, N/A, Warsaw, IN, United States
Products
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0740-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief