BEUDAMED
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    ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWA·January 28, 2011

    Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

    FDA Recall
    Terminated ·Arcos, Inc·Product code PDT·March 16, 2015

    Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

    FDA Enforcement
    Class II ·Terminated·Arcos, Inc·August 28, 2019

    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·September 14, 2016

    Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth.

    FDA Recall
    Terminated ·Highland Metals·Product code D·July 12, 2011

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    FDA Enforcement
    Class II ·Terminated·Highland Metals, Inc.·February 12, 2014

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    FDA Enforcement
    Class II ·Terminated·Highland Metals, Inc.·February 12, 2014

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    FDA Recall
    Terminated ·Highland Metals, Inc.·Product code DZC·December 13, 2013

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    FDA Recall
    Terminated ·Highland Metals, Inc.·Product code DZC·December 13, 2013

    Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model KS1006

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 30, 2006

    Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·September 8, 2008

    BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 23, 2006

    ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 15, 2007

    Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 30, 2004

    Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers CDB8003-01-US and CDB8053-01-US (with scale)

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·June 8, 2004

    BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·November 13, 2006

    Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient Lift; Model KM560101; BHM Medical Inc., Magog, QC, Canada The Maxi 500 is a mobile passive lift intended to be for lifting and transferring of patients in hospitals, nursing homes, or other health care facilities.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 20, 2008

    Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Model KDB1890-04US - Ambulift Classic with chair and leg rest. Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·May 5, 2008

    Ambulift, standard basic model manually powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Model AB1102 - Standard basic model Ambulift with chair and leg rest. Model AB1552 - Standard basic model Ambulift with chair and leg rest and scales.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·May 5, 2008

    Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·January 30, 2003