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Terminated

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

FDA Recall Z-1235-2018 · Posted 2018-03-14

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2017-12-20
Date Terminated2020-04-22
Product Quantity3454

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.

Firm Action

On December 22, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers with a complete list of products subject to recall and requesting that the customer review the notification and notify all affected personnel of the recall. If there is affected product at the facility it is requested that these units be quarantined and returned to a sales representative for return to the firm. Questions or concerns can be directed to 574-371-3071.

Root Cause

Device Design

Distribution Pattern

USA (nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111663TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc. · 2012-03-12K042325TROCHANTERIC NAIL SYSTEMDePuy Orthopaedics, Inc. · 2004-09-08K013563LONG TROCHANTERIC NAIL SYSTEMDePuy Orthopaedics, Inc. · 2001-12-27K010780TROCHANTERIC NAILDePuy Orthopaedics, Inc. · 2001-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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