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510(k) K111663 · HRS Plate, Fixation, Bone

TRAUMA INTERNAL FIXATION SYSTEMS

Applicant	DePuy Orthopaedics, Inc., Warsaw IN, US
Decision	Substantially Equivalent, Mar 12, 2012
Received	Jun 14, 2011
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K111663

Date	Firm and product	Code	Linked 510(k)
Feb 14, 2022	Biomet, Inc. BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient re Terminated	JDR	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Mar 14, 2018	Zimmer 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	HSB	None listed
Oct 25, 2017	Zimmer Biomet, Inc. A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403 Terminated	HRS	None listed
May 26, 2016	Biomet, Inc. Various trauma and sports medicine instruments and implants. Plate, fixation, bone. Terminated	HRS	None listed
Dec 18, 2015	Biomet, Inc. A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones. Terminated	HRS	None listed
Jul 10, 2015	Biomet, Inc. A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw Terminated	HRS	None listed
Jul 8, 2015	Biomet, Inc. A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. Terminated	HRS	None listed

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