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Sources: EU EUDAMED, US FDA
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POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code LXH·January 12, 2011
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 15 hole, Sterile, REF 8141-30-115, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 18 hole, Sterile, REF 8141-31-118, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-112, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 6 hole, Sterile, REF 8141-31-106, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 9 hole, Sterile, REF 8141-31-109, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 18 hole, Sterile, REF 8141-30-118, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 9 hole, Sterile, REF 8141-30-109, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 12 hole, Sterile, REF 8141-30-112, Depuy Orthopaedics, Inc., Warsaw, IN.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
FDA Recall
Terminated
·Depuy Orthopaedics Inc.·Product code MEH·October 25, 2016
Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KTT·October 30, 2007
Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, DePuy Orthopaedics, Inc., Warsaw, IN 46581
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KTT·October 30, 2007
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·November 8, 2016
CORAIL HIGH OFFSET STEM Collarless SIZE 14
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWL·July 12, 2017
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWL·July 12, 2017
SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWS·July 13, 2007
DePuy Attune Impaction Handle Warsaw, IN 46582 Packaging: Product is packed within a polyethylene bag, with protection added as needed for sharp and/or fragile points. Product Usage: The ATTUNE Impaction handle is intended to act as a removable interface for several of the instruments that may be used throughout a procedure. The Attune Impaction Handle is used to impact, insert, and extract various Attune Instruments. The handle interfaces with the Keel Punch, Tibial Tower, Evaluation Bullet, Fixed Bearing Tibial Impactor, Rotating Platform Tibial Impactor and the Femoral Impactor.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·March 16, 2012
Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code MDM·August 27, 2014
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C. SIGMA knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C. SIGMA Specialist 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C. SIGMA Specialist 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. SIGMA High Performance (HP) Primary Knee Instruments
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·September 8, 2015