BEUDAMED
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    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·September 30, 2013

    Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·February 23, 2005

    Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWA·June 30, 2008

    Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code HWA·July 24, 2019

    Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HWA·August 28, 2017

    Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignment guide. Catalog No. 1440-1370 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. Authorized Representative in Europe: Stryker France, Cedex France. The correct position of the cup relative to the pelvic reference planes can be achieved by the use of the alignment guide.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·April 27, 2006

    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE

    FDA Recall
    Terminated ·Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand·Product code HWA·August 16, 2019

    Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CHA62 Tll340 SHP9109.00010 T8043 ~ MMP3100CHA04 T17321 MMPP3100CHA04 T15311 GG920010029 T1 7650 255000110 T8143 803-t 1-103 Tl4384 EK-00200690 T1666t XEB227242 T9316 MIMP3100CHA04 Tl3642 500325 T10753 ~MMP3100CH04 T9348 ~ MMP3100CHA04 T13480 MMP3100CHA042 T10243 ~MIMP3001CHA08 Tll209 ~ MMP300CHA12 Tl0861 MMP3100CHA04 T16427 MMP3100CHA04 T9894 :-. MMP3100CHA04 T12861 MMP3100CHA\041 T8088 2002CUPI T1661 1 T16611 Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code HWA·August 2, 2016

    EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

    FDA Recall
    Terminated ·Product code HWA·August 9, 2007

    Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWA·October 14, 2014

    Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

    FDA Recall
    Terminated ·XTANT Medical·Product code HWA·May 12, 2020

    Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HWA·October 14, 2014

    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.

    FDA Recall
    Terminated ·Product code HWA·September 14, 2015

    Turon Impaction Fixture

    FDA Recall
    Terminated ·Product code HWA·February 9, 2017

    The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points, distributed by DePuy International Leeds, UK. Instruments are supplied non-sterile and do not have specified expiration date or shelf life. Usage: The Tibial Tray (with protective cover) and instrument are assembled outside of the patient in theatre; the tray is introduced and impacted into the cement containing tibia using the impactor. Once the tray is fully seated in the cement containing tibia, the instrument is intended to be removed.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code HWA·December 13, 2011

    Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384, T15311, T15752, T15822, T15949, T16117, T16427, T16604, T16611, T16661, T16829, T16934, T17062, T17203, T17238, T17321, T6318, T7821, T8042, T8043, T8044, T8087, T8088, T8093, T8095, T8177, T8184, T8277, T8310, T8333, T8468, T8487, T9109, T9196, T9205, T9316, T9348, T9360, T9556, T9557, T9747, T9894, T9954, T9955, T9999. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). EXPANDED 3-28-2014: The following Part Numbers are also affected: P10270, P6427, P6464, P6501, P7611, P7640, P7794, P7927, P8233, P8590, T10006, T10261, T10606, T10835, T11095, T11506, T11622, T12081, T12083, T12124, T12125, T13435, T13527, T14174, T15262, T15515, T16418, T16551, T16552, T16553, T17272, T5709, T6744, T7751, T9195.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code HWA·January 31, 2014

    Trident Insert Impactor

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics·Product code HWA·April 28, 2003

    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·September 30, 2013

    Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.

    FDA Recall
    Terminated ·Product code HWA·September 14, 2015

    Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Impactor/Extractor is used for insertion and removal of a tibial baseplate during total knee arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·July 2, 2008