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Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125
Recalled April 4, 2018 · FDA recall Z-1235-2018 · Zimmer Biomet
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. · FDA Class II
Units
3454
Sold at
USA (nationwide)
Description
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.
Product
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
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →