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Linvatec Corporation d/b/a ConMed Linvatec

United Statesfrom the FDA registration address FDA establishment FEI 1017294

Devices
4
Registrations
FDA
FDA recalls
60

What Linvatec Corporation d/b/a ConMed Linvatec makes

The company manufactures orthopedic and soft-tissue fixation devices, including suture anchors for ligament and tendon repairs, such as the Y-KNOT FLEX and NANO SUTURE ANCHOR, as well as drive systems for surgical implantation like the D4000 and D4000A with irrigation. These products are designed for arthroscopic and open surgical procedures, supporting procedures in joints like the shoulder, knee, and elbow.

The portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) pathway. These devices are listed under the US regulatory framework and are manufactured by a company based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

Company details

FDA FEI number
1017294
Address
11311 Concept Boulevard, LARGO, FL, 33773

FDA recalls60

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 60 recalls initiated by Linvatec Corporation d/b/a ConMed Linvatec, the earliest on 2009-07-31 and the most recent on 2013-05-30. By recorded status: 60 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 60 recalls.

  • 2013

    • 30 May 2013 Z-1680-2013 Class II Terminated Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. Distribution: Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK,…
      Full distribution text Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.
      Submission number: K954440
    • 30 May 2013 Z-1681-2013 Class II Terminated Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. Distribution: Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK,…
      Full distribution text Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.
      Submission number: K961590
    • 18 Mar 2013 Z-1340-2013 Class II Terminated The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue. Distribution: Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA,…
      Full distribution text Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.
    • 6 Mar 2013 Z-1619-2013 Class II Terminated Incorrect blue/white suture was used. Distribution: US Distribution including the states of FL, KY, LA, MI, NC, and NY. Submission number: K101100
    • 24 Jan 2013 Z-0916-2013 Class III Terminated The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance. Distribution: Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and…
      Full distribution text Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore
      Submission number: K050519
    • 24 Jan 2013 Z-0917-2013 Class III Terminated The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance. Distribution: Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and…
      Full distribution text Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore
      Submission number: K050519

  • 2012

    • 15 Nov 2012 Z-0789-2013 Class II Terminated ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm. Distribution: Worldwide Distribution - USA including California and Internationally to Spain and Korea
    • 6 Jul 2012 Z-2151-2012 Class II Terminated ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. Distribution: Worldwide Distribution -- US and Korea.
    • 26 Jun 2012 Z-0063-2013 Class II Terminated Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. Distribution: Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA.…
      Full distribution text Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
      Submission number: K112965
    • 26 Jun 2012 Z-0064-2013 Class II Terminated Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. Distribution: Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA.…
      Full distribution text Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
      Submission number: K112965
Show the 25 most recent of 60 recalls

  • 2012

    • 26 Jun 2012 Z-0065-2013 Class II Terminated Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. Distribution: Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA.…
      Full distribution text Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
      Submission number: K112965
    • 26 Jun 2012 Z-0066-2013 Class II Terminated Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. Distribution: Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA.…
      Full distribution text Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
      Submission number: K112965
    • 26 Jun 2012 Z-0067-2013 Class II Terminated Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. Distribution: Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA.…
      Full distribution text Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
      Submission number: K112965
    • 26 Jun 2012 Z-0068-2013 Class II Terminated Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. Distribution: Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA.…
      Full distribution text Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
      Submission number: K112965
    • 10 Apr 2012 Z-0383-2013 Class II Terminated Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. Distribution: Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and…
      Full distribution text Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
    • 10 Apr 2012 Z-0384-2013 Class II Terminated Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. Distribution: Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and…
      Full distribution text Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
    • 9 Apr 2012 Z-0164-2013 Class II Terminated ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle. Distribution: Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand

  • 2011

    • 12 Aug 2011 Z-2147-2012 Class II Terminated ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion. Distribution: Nationwide Distribution, including the states of Colorado and Pennsylvania.
    • 1 Jul 2011 Z-2469-2012 Class II Terminated ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents. Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA,…
      Full distribution text Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.
    • 20 May 2011 Z-2455-2012 Class II Terminated Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA. Submission number: K070376
    • 20 May 2011 Z-2456-2012 Class II Terminated Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA. Submission number: K070376
    • 26 Jan 2011 Z-2703-2011 Unclassified (pre-2012) Terminated ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black). Distribution: Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa.

  • 2010

    • 30 Nov 2010 Z-1880-2011 Unclassified (pre-2012) Terminated On Nov 30, 2010 ConMed Linvatec, Largo, FL recalled their Micro Sagittal Blade, Fine Lot number 180209, Product Number 5023-138. Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging. Distribution: Worldwide Distribution - USA including CT, FL, GA, HI, IN, MO, MS, MT, NJ, NY, OH, PA, SC, and TX and the countries of…
      Full distribution text Worldwide Distribution - USA including CT, FL, GA, HI, IN, MO, MS, MT, NJ, NY, OH, PA, SC, and TX and the countries of Canada, and South Africa.
    • 17 Sep 2010 Z-1893-2011 Unclassified (pre-2012) Terminated If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement. Distribution: Worldwide Distribution -- Australia, Canada, Morocco, Saudi Arabia, Taiwan, Province of China, and throughout the U.S.
    • 10 Sep 2010 Z-1821-2011 Unclassified (pre-2012) Terminated On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field. Distribution: Worldwide Distribution - USA (nationwide) and internationally to Saudi Arabia, Italy, France, Canada, Portugal, South…
      Full distribution text Worldwide Distribution - USA (nationwide) and internationally to Saudi Arabia, Italy, France, Canada, Portugal, South Africa, Switzerland, Denmark, Germany, New Zealand, Australia, and Spain.

Frequently asked questions

How many devices does Linvatec Corporation d/b/a ConMed Linvatec have in the registry?

The registry currently lists 4 devices for Linvatec Corporation d/b/a ConMed Linvatec. Devices recorded under merged duplicate company entries are counted once.

Which registries list Linvatec Corporation d/b/a ConMed Linvatec's devices?

Among its 4 most recently registered devices, Linvatec Corporation d/b/a ConMed Linvatec has devices listed in FDA 510(k) (4 devices).

What risk classes do Linvatec Corporation d/b/a ConMed Linvatec's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Linvatec Corporation d/b/a ConMed Linvatec's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Linvatec Corporation d/b/a ConMed Linvatec?

FDA recall records list 60 recalls initiated by Linvatec Corporation d/b/a ConMed Linvatec, the most recent initiated on 30 May 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Linvatec Corporation d/b/a ConMed Linvatec in the registry?

The most recently registered devices listed for Linvatec Corporation d/b/a ConMed Linvatec include Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM, D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION, NANO SUTURE ANCHOR and GENESYS PRESSFT SUTURE ANCHOR.

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

This is an FDA establishment record. No EUDAMED registration is known for this company.