BEUDAMED
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    OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWT·March 9, 2005

    OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWT·March 9, 2005

    Accolade HFx These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·November 13, 2008

    Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 13, 2008

    OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons on proper surgical technique.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009

    Accolade System Surgical Technique; Accolade C - Cemented Hip Stem; Accolade TMZF Cementless Hip System; Accolade HFx Cementless Hip System. Stryker Orthopaedics. Surgical protocols instruct surgeons on proper surgical technique.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009

    Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corp·Product code HFX·April 12, 2005

    Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011

    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HFX·September 8, 2014

    DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011

    Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

    FDA Recall
    Terminated ·Surgical Design Inc·Product code HFX·January 26, 2011

    Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code HFX·August 28, 2019

    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HFX·October 28, 2016

    Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corp·Product code HFX·April 12, 2005

    Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code HFX·August 28, 2019

    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code HFX·January 16, 2014

    A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HFX·September 8, 2014

    Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

    FDA Enforcement
    Class II ·Terminated·Vascular Solutions, Inc.·June 27, 2018

    Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·March 7, 2018