FDA-Device2018-04-04Class II
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H TROC NAIL 320X11X125 STER L H TROC NAIL 340X11X125 STER L H TROC NAIL 360X11X125 STER L H TROC NAIL 380X11X125 STER L H TROC NAIL 400X11X125 STER L H TROC NAIL 420X11X125 STER L H TROC NAIL 440X11X125 STER L H TROC
Zimmer Biomet, Inc.
Hazard
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
Sold states
USA (nationwide)
Affected count
3454
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H TROC NAIL 320X11X125 STER L H TROC NAIL 340X11X125 STER L H TROC NAIL 360X11X125 STER L H TROC NAIL 380X11X125 STER L H TROC NAIL 400X11X125 STER L H TROC NAIL 420X11X125 STER L H TROC NAIL 440X11X125 STER L H TROC NAIL 460X11X125 STER L H TROC NAIL 320X13X125 STER L H TROC NAIL 340X13X125 STER L H TROC NAIL 360X13X125 STER L H TROC NAIL 380X13X125 STER L H TROC NAIL 400X13X125 STER L H TROC NAIL 420X13X125 STER L H TROC NAIL 440X13X125 STER L H TROC NAIL 460X13X125 STER R H TROC NAIL 320X9X125 STER R H TROC NAIL 340X9X125 STER R H TROC NAIL 360X9X125 STER R H TROC NAIL 380X9X125 STER R H TROC NAIL 400X9X125 STER R H TROC NAIL 420X9X125 STER R H TROC NAIL 440X9X125 STER R H TROC NAIL 460X9X125 STER R H TROC NAIL 320X11X125 STER R H TROC NAIL 340X11X125 STER R H TROC NAIL 360X11X125 STER R H TROC NAIL 380X11X125 STER R H TROC NAIL 400X11X125 STER R H TROC NAIL 420X11X125 STER R H TROC NAIL 440X11X125 STER R H TROC NAIL 460X11X125 STER R H TROC NAIL 320X13X125 STER R H TROC NAIL 340X13X125 STER R H TROC NAIL 360X13X125 STER R H TROC NAIL 380X13X125 STER R H TROC NAIL 400X13X125 STER R H TROC NAIL 420X13X125 STER R H TROC NAIL 440X13X125 STER R H TROC NAIL 460X13X125 STER L H TROC NAIL 320X11X130 STER L H TROC NAIL 320X9X130 STER L H TROC NAIL 340X9X130 STER L H TROC NAIL 360X9X130 STER L H TROC NAIL 380X9X130 STER L H TROC NAIL 400X9X130 STER L H TROC NAIL 420X9X130 STER L H TROC NAIL 440X9X130 STER L H TROC NAIL 460X9X130 STER L H TROC NAIL 340X11X130 STER L H TROC NAIL 360X11X130 STER L H TROC NAIL 380X11X130 STER L H TROC NAIL 400X11X130 STER L H TROC NAIL 420X11X130 STER L H TROC NAIL 440X11X130 STER L H TROC NAIL 460X11X130 STER L H TROC NAIL 320X13X130 STER L H TROC NAIL 340X13X130 STER L H TROC NAIL 360X13X130 STER L H TROC NAIL 380X13X130 STER L H TROC NAIL 400X13X130 STER L H TROC NAIL 420X13X130 STER L H TROC NAIL 440X13X130 STER L H TROC NAIL 460X13X130 STER R H TROC NAIL 320X9X130 STER R H TROC NAIL 340X9X130 STER R H TROC NAIL 360X9X130 STER R H TROC NAIL 380X9X130 STER R H TROC NAIL 400X9X130 STER R H TROC NAIL 420X9X130 STER R H TROC NAIL 440X9X130 STER R H TROC NAIL 460X9X130 STER R H TROC NAIL 320X11X130 STER R H TROC NAIL 340X11X130 STER R H TROC NAIL 360X11X130 STER R H TROC NAIL 380X11X130 STER R H TROC NAIL 400X11X130 STER R H TROC NAIL 420X11X130 STER R H TROC NAIL 440X11X130 STER R H TROC NAIL 320X13X130 STER R H TROC NAIL 340X13X130 STER R H TROC NAIL 360X13X130 STER R H TROC NAIL 380X13X130 STER R H TROC NAIL 400X13X130 STER R H TROC NAIL 420X13X130 STER R H TROC NAIL 440X13X130 STER R H TROC NAIL 460X13X130 STER L H TROC NAIL 320X9X135 STER L H TROC NAIL 340X9X135 STER L H TROC NAIL 360X9X135 STER L H TROC NAIL 380X9X135 STER L H TROC NAIL 400X9X135 STER L H TROC NAIL 420X9X135 STER L H TROC NAIL 440X9X135 STER L H TROC NAIL 460X9X135 STER L H TROC NAIL 320X11X135 STER L H TROC NAIL 340X11X135 STER L H TROC NAIL 360X11X135 STER L H TROC NAIL 380X11X135 STER L H TROC NAIL 400X11X135 STER L H TROC NAIL 420X11X135 STER L H TROC NAIL 440X11X135 STER L H TROC NAIL 460X11X135 STER L H TROC NAIL 320X13X135 STER L H TROC NAIL 340X13X135 STER L H TROC NAIL 360X13X135 STER L H TROC NAIL 380X13X135 STER L H TROC NAIL 400X13X135 STER L H TROC NAIL 420X13X135 STER L H TROC NAIL 440X13X135 STER L H TROC NAIL 460X13X135 STER R H TROC NAIL 320X13X135 STER R H TROC NAIL 340X13X135 STER R H TROC NAIL 360X13X135 STER R H TROC NAIL 380X13X135 STER R H TROC NAIL 400X13X135 STER R H TROC NAIL 420X13X135 STER R H TROC NAIL 440X13X135 STER R H TROC NAIL 460X13X135 STER R H TROC NAIL 320X9X135 STER R H TROC NAIL 340X9X135 STER R H TROC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2018Don't want to check this manually?
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