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    Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·May 19, 2009

    3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field.

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·December 27, 2005

    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code GCX·March 28, 2018

    Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal.

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·August 21, 2009

    Left Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Proximal Metatarsal Wedge Plate... REF 70-0010-S... LOT W58118".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·June 29, 2007

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    Locking Clavicle Plate, 8 Holes Medium Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Right ... REF PL-CL8MR-S LOT W58195".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Locking Clavicle Plate, 9 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Right... REF PL-CL9JR-S LOT W58199 ".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".

    FDA Recall
    Terminated ·Acumed LLC·Product code JDQ·March 28, 2008

    Locking Clavicle Plate, 8 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Right... REF PL-CL8JR-S LOT W57686".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... LOT W58115".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Locking Clavicle Plate, 10 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 10 Holes Large Left... REF PL-CL10LL-S... LOT W58181".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Locking Clavicle Plate, 8 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Large Left ... REF PL-CL8LL-S."

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Locking Clavicle Plate, 8 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Left... REF PL-CL8JL-S."

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Locking Clavicle Plate, 8 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Small Right ... REF PL-CL8SR-S."

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Locking Clavicle Plate, 6 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 6 Holes Small Right ... REF PL-CL6SR-S LOT W57684".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... LOT W58120".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Locking Clavicle Plate, 10 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 10 Holes Large Right... REF PL-CL10LR-S."

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036-S... LOT W58123".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008