Recall Z-1225-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1225-2018
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 ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.. 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 ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

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.