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    Filters FDA Recall × Status: Terminated × Clear all

    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

    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

    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

    10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE" The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.

    FDA Recall
    Terminated ·Acute Innovations Llc·Product code HRS·February 28, 2011

    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

    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

    6mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 6mm Bone Graft Drill... REF BG-8006-S ... LOT W51258".

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