ClearanceBrief
510(k) K042325 ยท HSB Rod, Fixation, Intramedullary And Accessories

TROCHANTERIC NAIL SYSTEM

ApplicantDePuy Orthopaedics, Inc., Warsaw IN, US
DecisionSubstantially Equivalent, Sep 8, 2004
ReceivedAug 27, 2004
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K042325

DateFirm and productCodeLinked 510(k)
Mar 14, 2018Zimmer Biomet, Inc.
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 1
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intend
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal frac
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertr
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable prox
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stab
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable prox
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat st
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG S
Terminated		 HSBNone listed
Mar 14, 2018Zimmer Biomet, Inc.
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 420X9X1
Terminated		 HSBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.