BEUDAMED
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    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

    FDA Recall
    Terminated ·SSC- Surgical Specialties Corporation·Product code GAW·May 20, 2016

    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    FDA Enforcement
    Class II ·Terminated·Kimberly-Clark Corporation·July 25, 2012

    Video Cart Multi-Specialty product labeling is as follows: REF, VP6502, QTY1, Video Cart Multi-Specialty, 120V, Rx ONLY, These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code KQM·February 23, 2010

    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    FDA Recall
    Terminated ·Surgical Specialties Mexico S DE RL DE CV Corredor Tijuana Rosarito 2000-24702 B Ejido Francisco Villa Tijuana Mexico·Product code OMT·September 24, 2016

    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016

    CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LXH·November 1, 2010

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Straight Command Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Locking Accolade Straight Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Woodpecker Adapted Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430 The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures. The rasps have a geometry similar to the final size and shape of the implant. The straight design allows the rasp handle to be used in standard or minimally invasive approaches because it minimizes the contact with adjacent soft tissue. The Handle is impacted with a slotted mallet on the top and on the bottom portions of the striking plate, to achieve rasp insertion and extraction respectively. The handles share the same geometry in the region that is of interest in this matter.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LXH·August 19, 2011

    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

    FDA Enforcement
    Class II ·Terminated·SSC- Surgical Specialties Corporation·June 29, 2016

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GEA·November 5, 2002

    Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code HNN·January 7, 2003

    Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GAR·September 24, 2005

    Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code HNN·August 21, 2003

    SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code DTH·March 30, 2011

    Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GAT·August 25, 2003

    3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GAR·September 9, 2008

    25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GEA·November 5, 2002

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012