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ArthroCare Corporation

Active in EUDAMED
Also registered as Arthrocare Corp.

United Statesfrom SRN EUDAMED FDA SRN US-MF-000017581 FEI 3010813691

Devices
155
Registrations
EUDAMEDFDA
FDA recalls
140 ongoing since 2021 (1 open in total)
1 open since before 2021

What ArthroCare Corporation makes

ArthroCare Corporation manufactures surgical instruments and systems for arthroscopic and endoscopic procedures, including plasma-based wand devices for tissue ablation, irrigation tools, and hemostasis wands. Their portfolio includes suture anchors for soft tissue fixation, nasal dressings, and coblation systems for precise tissue removal or coagulation. Additional products cover arthroscopic tools like drills, guides, and knot pushers, as well as knotted fixation systems for joint repairs.

The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) clearance database. Products are designed for orthopedic, ENT, and nasal applications, with listings reflecting their authorised use in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue155

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Company details

EUDAMED SRN
US-MF-000017581
FDA FEI number
3010813691
EUDAMED status
Active
EUDAMED registered name
ArthroCare Corporation
Registered address
7000, W. William Cannon Drive, 78735-8531, Austin, Texas, United States
Phone
+1 (512) 656-2543
PRRC contact
Angela Mejia(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 25 Sep 2027

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 077112 0053 Expiring Reissued Expires in 328 days

    Quality management system EU MDR

    Issued
    24 Jun 2025
    Expires
    25 Sep 2027

FDA recalls14

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

12 initiated before 2017

Showing the 10 most recent of 14 recalls.

  • 2020

    • 17 Aug 2020 Z-2999-2020 Class II Open since 2020 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 Distribution: Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND,…
      Full distribution text Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV. International Distribution: AE, AU, CH, DE, FI, FR, GB, HK, IE, PA, PR, PT, RU, SG, and ZA
      Submission number: K163142

  • 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 Distribution: US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV,…
      Full distribution text US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, SC, SG, TN, TX, UT, VA, WA, WI, WV OUS: Austria, Belgium, Canada, Switzerland, Germany, Denmark, France, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)
      Submission number: K123268

  • 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 Distribution: Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia,…
      Full distribution text Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, China, Hong Kong, India, Lebanon, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arabic Emirates, Vietnam, Australia, Japan, New Zealand, Brazil, and Chile.
      Submission number: K080282

  • 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 Distribution: Worldwide distribution. US nationwide including OH, MO, AZ, AL, CA, FL, SC, GA, and PA; Spain, France, United Kingdom,…
      Full distribution text Worldwide distribution. US nationwide including OH, MO, AZ, AL, CA, FL, SC, GA, and PA; Spain, France, United Kingdom, Germany, Switzerland, Singapore, Russia, Turkey, and Ecuador.
      Submission number: K063172
    • 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 Distribution: Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland,…
      Full distribution text Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
      Submission numbers: K070374, K142999

  • 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 Distribution: Nationwide distribution: USA including states of: CA, FL, NY, OH and OK. Submission number: K042584

  • 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 Distribution: Product was released for distribution in US. Submission number: K090615

  • 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 Distribution: Worldwide Distribution including USA and countries of Netherlands, Slovak Republick, Ireland, Spain, Switzerland,…
      Full distribution text Worldwide Distribution including USA and countries of Netherlands, Slovak Republick, Ireland, Spain, Switzerland, Singapore, Russian Federatin, Greece, Japan, Saudi Arabia, India, Slovenia, Israel, South Africa, South Korea, Poland, Thailand, Jordan, Belgium, Finland, Portugal, Cyprus, Italy, UAE, Kuwait, China, Bahrain, Denmark, Norway, Sweden, Australia, Germany, Austria, UK, New Zealand, Mexico and Canada.
      Submission number: K030551
    • 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 Distribution: Product was distributed to 247 consignees throughout the US and to Australia, Germany, Italy, UK, Austria, Netherlands,…
      Full distribution text Product was distributed to 247 consignees throughout the US and to Australia, Germany, Italy, UK, Austria, Netherlands, Switzerland, Denmark, South Africa, Finland, Singapore, Spain, Russia and Poland.
      Submission number: K033584
    • 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 Distribution: Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MN,…
      Full distribution text Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and countries of Sweden, Australia, Germany, Italy, UK, Austria, Saudi Arabia, Belgium, Portugal, UAE, Kuwait, Singapore, Ireland, Spain, Finland, South Korea, Russia and Vietnam.
      Submission number: K053567
Show all 14 recalls

  • 2006

    • 28 Jun 2006 Z-1312-06 Unclassified (pre-2012) Terminated The product may lose sterility due to omission of the final pouch seal.via FDA establishment Arthrocare Corporation Distribution: Nationwide. Submission number: K022229
    • 7 Jun 2006 Z-1186-06 Unclassified (pre-2012) Terminated Potential loss of product sterility due to breach of pouch seal.via FDA establishment Arthrocare Corporation Distribution: Worldwide Submission number: K022229
    • 7 Jun 2006 Z-1187-06 Unclassified (pre-2012) Terminated Potential loss of product sterility due to breach of pouch seal.via FDA establishment Arthrocare Corporation Distribution: Worldwide Submission number: K022229

  • 2005

    • 12 Jul 2005 Z-1043-05 Unclassified (pre-2012) Terminated Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infectionvia FDA establishment Arthrocare Corporation Distribution: The product was distributed to 19 consignees in foreign countries, including Denmark, Spain, Lebanon, Finland, Saudi…
      Full distribution text The product was distributed to 19 consignees in foreign countries, including Denmark, Spain, Lebanon, Finland, Saudi Arabia, the UK, Egypt, Italy, and Australia, as well as 12 medical facilities in New Jersey, New York, Ohio, Maryland, Montana, Oregon, Illinois, Washington, Wisconsin and Nevada. Dates of distribution and manufacture are approximations, provided by the recalling firm.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Arthrocare Corporation Coyol Alajuela · CR FEI 3012358417

Frequently asked questions

How many devices does ArthroCare Corporation have in the registry?

The registry currently lists 155 devices for ArthroCare Corporation. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for ArthroCare Corporation?

FDA recall records list 14 recalls initiated by ArthroCare Corporation, the most recent initiated on 17 Aug 2020. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for ArthroCare Corporation?

EUDAMED lists 1 certificate for ArthroCare Corporation (quality management system) under MDR. The most recent was issued on 24 Jun 2025.

Which FDA establishments are linked to ArthroCare Corporation?

1 FDA establishment is linked to ArthroCare Corporation in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.