Recall Z-1235-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1235-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-20

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-12-20, terminated 2020-04-22. It names 4 FDA 510(k) clearances: K111663, K042325, K013563 and 1 more. 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. Reason: 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Terminated: 2020-04-22
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

4 on FDA's record

K111663 — TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc.·cleared 2012-03-12
K042325 — TROCHANTERIC NAIL SYSTEMDePuy Orthopaedics, Inc.·cleared 2004-09-08
K013563 — LONG TROCHANTERIC NAIL SYSTEMDePuy Orthopaedics, Inc.·cleared 2001-12-27
K010780 — TROCHANTERIC NAILDePuy Orthopaedics, Inc.·cleared 2001-06-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.