ArthroCare Corporation

• ARTHRO Class IIb ARTC-TF-037 Intellio Shift Non-Network Enabled Controller and Foot Pedal Ref 72290192

  Class IIb EUDAMED Active

• ARTHRO Class IIb ARTC-TF-037 Intellio Shift Non-Network Enabled Controller and Foot Pedal Ref 72290263

  Class IIb EUDAMED Active

• ARTHRO Class IIb ARTC-TF-037 Intellio Shift Non-Network Enabled Controller and Foot Pedal Ref 72290191

  Class IIb EUDAMED Active

• ARTHRO Class IIb ARTC-TF-037 Intellio Shift Non-Network Enabled Controller and Foot Pedal Ref 72290194

  Class IIb EUDAMED Active

• Arthro Class IIb ARTC-TF-038 FLOW FLEXTEND COBLATION Wand Ref 72290039

  Class IIb EUDAMEDFDA UDI Active

• ARTHRO Class IIb ARTC-TF-037 Intellio Shift Non-Network Enabled Controller and Foot Pedal Ref 72290193

  Class IIb EUDAMED Active

• FLOW FLEXTEND Wand (72290039) Ref K254122

  Class II FDA 510(k) Active

• Arthrocare Arthroscopic Eletrosurgery System (Model 980) Ref K963123

  Class II FDA 510(k) Active

• EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable Ref K142999

  Class II FDA 510(k) Active

• Modification To Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands And Spine Wands Ref K000511

  Class II FDA 510(k) Active

• Opus Smartstitch Suture Device Ref K070671

  Class II FDA 510(k) Active

• AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches Ref K180848

  Class II FDA 510(k) Active

• RF20000a Controller, FLOW 50 Wand Ref K143235

  Class II FDA 510(k) Active

• Arthrocare Bipolar Loop Electrode System Ref K955531

  Class II FDA 510(k) Active

• Magnum Mp Fixation Device Ref K091503

  Class II FDA 510(k) Active

• Modificaton To: Arthrocare Arthrowands Ref K072865

  Class II FDA 510(k) Active

• Arthrocare Percd Spinewand Ref K030954

  Class II FDA 510(k) Active

• Arthrocare Nasastent Cmc Nasal Dressing Ref K140992

  Class I FDA 510(k) Active

• Arthrocare Urologic Multi-Electrode Electrosurgery System Ref K961069

  Class II FDA 510(k) Active

• Arthrocare Orthowand Surgical Device Ref K080610

  Class II FDA 510(k) Active

• Opus Magnum Speedscrew Knotless Fixation Device, Model Om-6500 Ref K081893

  Class II FDA 510(k) Active

• Arthrocare Arthroscopic Electrosurgery System (Model 970) Ref K961747

  Class II FDA 510(k) Active

• Q-Fix Suture Anchor Ref K172165

  Class II FDA 510(k) Active

• Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model 72202139, 72202141, 72202143, 72202144 Ref K090393

  Class II FDA 510(k) Active

• Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System Ref K220563

  Class II FDA 510(k) Active

• Q-Fix Suture Anchor, 1.8mm; Q-Fix Suture Anchor, 2.8mm; Drill, Drill Guide And Obturator, 1.8mm & 2.8mm, Firstpass Sutu Ref K133727

  Class II FDA 510(k) Active

• Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands And Spinewands Ref K000044

  Class II FDA 510(k) Active

• Q-Fix Suture Anchor, 1.8mm And 2.8mm / Drill, Drill Guide And Obturator, 1.8mm And 2.8mm /Bone Punch, 2.8mm And Knot Pusher Ref K132513

  Class II FDA 510(k) Active

• ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System Ref K202006

  Class II FDA 510(k) Active

• Arthrocare Bipolar Electrosurgery System Ref K031029

  Class II FDA 510(k) Active

• Entec Evac Plasma Wand Ref K011279

  Class II FDA 510(k) Active

• Titan Ti Suture Anchor System Ref K111397

  Class II FDA 510(k) Active

• Parallax Ezflow Cement Delivery System Ref K051820

  Class I FDA 510(k) Active

• Spinewand Surgical Device Ref K091228

  Class II FDA 510(k) Active

• Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand Ref K210423

  Class II FDA 510(k) Active

• Multifix S Knotless Fixation System Ref K140604

  Class II FDA 510(k) Active

• Arthrocare Spinewand Ref K072089

  Class II FDA 510(k) Active

• Arthrocare System Ref K032504

  Class II FDA 510(k) Active

• Entec Reflex Wand 55, Model E4055-00 Ref K000036

  Class II FDA 510(k) Active

• Arthrocare Controllers (System 2000, 1100, 1200), Model H2076-00, H2079-00, H3000-00, H4000-00; Ref K080282

  Class II FDA 510(k) Active

• Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord Ref K001936

  Class II FDA 510(k) Active

• Arthrocare Controller (System 2000 And 8000); Arthrocare Cable; Foot Control; Power Cord; And Wands Ref K020622

  Class II FDA 510(k) Active

• Arthrocare Parallax Contour Vertebral Augmentation Device Ref K110183

  Class II FDA 510(k) Active

• Refinity System, Refinity Handpiece And Cable, Refinity Footswitch, Refinity Power Cord, Model V5100-00, V5701-00, V5702 Ref K003624

  Class II FDA 510(k) Active

• Ambient HipVac 50 Wand with Integrated Finger Switches Ref K161481

  Class II FDA 510(k) Active

• INTELLIO SHIFT System Ref K232290

  Class II FDA 510(k) Active

• Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) Ref K162126

  Class II FDA 510(k) Active

• Parallax Acrylic Resin Cartridge With Tracers-Ta Ref K060425

  Class II FDA 510(k) Active

• N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various Class I Ancill Ref K133606

  Class II FDA 510(k) Active

• Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand Ref K000228

  Class II FDA 510(k) Active

Showing the 10 most recent of 14 recalls.

• 2020

  • 17 Aug 2020 Z-2999-2020 Class II Ongoing Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.via FDA establishment Arthrocare Corporation

• 2019

  • 21 Feb 2019 Z-3000-2020 Class II Terminated The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.via FDA establishment Arthrocare Corporation

• 2016

  • 3 Mar 2016 Z-1321-2016 Class II Terminated During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.via FDA establishment Arthrocare Corporation

• 2015

  • 26 Oct 2015 Z-0623-2016 Class II Terminated There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.via FDA establishment Arthrocare Corporation
  • 2 Jun 2015 Z-2105-2015 Class II Terminated Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.via FDA establishment Arthrocare Corporation

• 2011

  • 11 May 2011 Z-0049-2012 Unclassified (pre-2012) Terminated ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.via FDA establishment Arthrocare Corporation

• 2010

  • 30 Sep 2010 Z-1952-2011 Unclassified (pre-2012) Terminated During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.via FDA establishment Arthrocare Corporation

• 2008

  • 5 Aug 2008 Z-1900-2009 Unclassified (pre-2012) Terminated Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.via FDA establishment Arthrocare Corporation
  • 9 Apr 2008 Z-2309-2008 Unclassified (pre-2012) Terminated Product is not secure in packaging, and movement may damage the product or render it non-sterile.via FDA establishment Arthrocare Corporation
  • 31 Jan 2008 Z-1657-2008 Unclassified (pre-2012) Terminated Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.via FDA establishment Arthrocare Corporation

• Arthrocare Corporation Coyol Alajuela · CR FEI 3012358417

Country

United States

Address

7000, W. William Cannon Drive , Austin, Texas, United States

Website

smith-nephew.com

Email

[email protected]

Phone

+1 (512) 656-2543

PRRC contact

Angela Mejia

EUDAMED SRN

US-MF-000017581

FDA FEI number

3010813691