The Recall Desk

Manufacturer

Linvatec Corp. dba ConMed Linvatec

21 recalls in our database name Linvatec Corp. dba ConMed Linvatec as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
0
Most recent
2013-07-17

Of the 21 recalls from Linvatec Corp. dba ConMed Linvatec we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • HighFDA (Devices)·Z-1680-2013·2013-07-17

    ConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect

    ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.

    Product
    ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2013·2013-07-17

    ConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect

    ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.

    Product
    ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1619-2013·2013-07-10

    ConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color

    ConMed Linvatec is recalling 60 units of Genesys Cross FT Suture Anchors because incorrect blue/white sutures were used instead of the specified type.

    Product
    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1340-2013·2013-05-29

    ConMed Linvatec VP1600 HD Still Capture System Software Recall

    ConMed Linvatec is recalling 267 VP1600 HD Still Capture Systems due to a software anomaly that may cause the device to lock up.

    Product
    Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0916-2013·2013-03-13

    Linvatec Recalls D3000 Advantage Drive Systems Due to Incorrect Panel Symbology

    Linvatec Corp. is recalling 31 D3000 Advantage Drive Systems because the front panel contains incorrect symbology, violating IEC60606-01 standards.

    Product
    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0917-2013·2013-03-13

    ConMed Linvatec Recalls D3000I Surgical Drive Systems Due to Incorrect Symbology

    ConMed Linvatec is recalling 23 D3000I Advantage Drive Systems because the membrane switch panel contains incorrect symbology, violating IEC60606-01 standards.

    Product
    D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0789-2013·2013-02-13

    ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter

    ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter is 4.5mm instead of the specified 3.5mm.

    Product
    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0384-2013·2012-11-28

    ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors

    ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.

    Product
    "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0383-2013·2012-11-28

    ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors

    ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.

    Product
    "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0164-2013·2012-11-07

    ConMed Linvatec Recalls Mis-assembled CrossFT Punches for Suture Anchor Insertion

    ConMed Linvatec is recalling 2 units of CrossFT Punches (Lot 330889) because they were mis-assembled with the incorrect handle.

    Product
    "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2013·2012-10-24

    ConMed Linvatec Recalls Press FT HI-FI Sutures Due to Driver Tip Separation

    ConMed Linvatec is recalling Press FT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0067-2013·2012-10-24

    ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0064-2013·2012-10-24

    ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0063-2013·2012-10-24

    ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0068-2013·2012-10-24

    ConMed Linvatec Recalls PressFT HI-FI Sutures Due to Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the distal tip of the driver may separate from the shaft after the implant is inserted.

    Product
    NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0066-2013·2012-10-24

    ConMed Linvatec Recalls PressFT HI-FI Sutures Due to Driver Tip Separation

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after the implant is inserted.

    Product
    "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2469-2012·2012-10-03

    ConMed Linvatec Recalls 24k Arthroscopy Outflow/Suction Tubing Sets

    ConMed Linvatec is recalling 24k Arthroscopy Outflow/Suction Tubing Sets because a potential breach in the Tyvek seal could compromise the sterility of the contents.

    Product
    Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic proc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2012·2012-10-03

    ConMed Linvatec Recalls Xenon Universal Light Source Devices

    ConMed Linvatec is recalling 57 Xenon Universal Light Source units used for endoscopic illumination due to a Class II recall.

    Product
    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2012·2012-10-03

    ConMed Linvatec Recalls Xenon Light Sources for Endoscopic Procedures

    ConMed Linvatec is recalling LS7700 and LS7600 Xenon Light Sources used to illuminate endoscopes during medical procedures.

    Product
    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2012·2012-08-15

    ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter

    ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter was 4.5mm instead of the intended 3.5mm.

    Product
    PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2147-2012·2012-08-15

    ConMed Linvatec Recalls CrossFT Punch Due to Incorrect Etching

    ConMed Linvatec is recalling 2 units of the CrossFT Punch (Lot #156920) because the device may have incorrect item numbers and depth lines.

    Product
    CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide