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Sources: EU EUDAMED, US FDA
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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
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·May 23, 2023
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 CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·March 2, 2023
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile; (5) Centurion CirClamp with 1.1cm Bell, Reorder #310CR, Sterile; (6) Centurion CirClamp with 1.1cm Bell Reprocessed, Reorder #310CRK, Sterile; (7) Centurion CirClamp with 1.3cm Bell, Reorder #330CR, Sterile; (8) Centurion CirClamp with 1.3cm Bell Reprocessed, Reorder #330CRK, Sterile; (9) Centurion CirClamp with 1.6cm Bell, Reorder #345CR, Sterile; (10) Centurion CirClamp with 1.45cm Bell, Reorder #3145CR, Sterile; (11) Centurion CirClamp with 1.1cm Bell & Insert Reprocessed, Reorder #CR210K, Sterile; (12) Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile; (13) Centurion CirClamp with 1.145cm Bell & Insert Reprocessed, Reorder #CR245K, Sterile; (14) Centurion CirClamp with 1.6cm Bell Reprocessed, Reorder #CR345K, Sterile; and (15) Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder #CR3145K.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·September 3, 2024
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