The Recall Desk

Manufacturer

Integra LifeSciences Corp.

217 recalls in our database name Integra LifeSciences Corp. as the manufacturing or recalling firm.

What the numbers show

Total
217
Critical
0
Severe
8
Most recent
2025-03-12

Of the 217 recalls from Integra LifeSciences Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (4%) 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.

151–175 of 217

  • ModerateFDA (Devices)·Z-1630-2018·2018-05-16

    Integra Manuka Honey Wound Gel Recalled for Incorrect Manufacturing Record

    Integra LifeSciences Corp. is recalling Manuka Honey Wound Gel due to an incorrect part number listed in a master manufacturing record.

    Product
    Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1487-2018·2018-05-02

    Integra LifeSciences Recalls TCC-EZ Total Contact Cast System

    Integra LifeSciences is recalling 250 units of the TCC-EZ Total Contact Cast System because a quarantined lot may produce excessive heat.

    Product
    TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2018·2018-05-02

    Integra LifeSciences Recalls Humeral Stem Trials for Breakage Risk

    Integra LifeSciences is recalling 1,619 humeral stem trials for the Titan Modular Shoulder System because they may break during surgery.

    Product
    The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Hum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2018·2018-03-07

    Integra CUSA Clarity Footswitch Recalled for Unintended Activation

    Integra LifeSciences is recalling 155 CUSA Clarity footswitches because a defect may cause unintended ultrasonic fragmentation activation during surgery.

    Product
    Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2017·2017-03-29

    Integra Recalls Panta Nails Due to Potential Sterility Seal Issues

    Integra LifeSciences is voluntarily recalling Panta and Panta XI Nails because package seals may not maintain intended sterility.

    Product
    Panta Nail, Rx only, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1410-2017·2017-03-15

    Integra UNI-CP System Recalled for Incorrect Labeling

    Integra LifeSciences Corp. is recalling 39 units of the UNI-CP System due to incorrect labeling on the plate.

    Product
    The UNI-CP System; Model Number: 330230SND.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1192-2017·2017-02-22

    Integra Cadence Total Ankle System Recalled Due to Tibial Fractures

    Integra LifeSciences Corp. is recalling 944 units of the Cadence Total Ankle System because posterior tibial fractures have been reported.

    Product
    Integra Cadence Total Ankle System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2909-2016·2016-10-12

    Integra Ventricular Catheter Accessory Kit Recalled for Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling 14 units of the Ventricular Catheter Accessory Kit due to an incomplete sterile packaging seal discovered during final inspection.

    Product
    Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2908-2016·2016-10-12

    Integra Drainage Accessory Kits Recalled Due to Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling specific lots of Integra Drainage Accessory Kits because a final inspection found an incomplete packaging seal, potentially compromising sterility.

    Product
    Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2905-2016·2016-10-12

    Integra Straight Ventricular Catheter Recalled for Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling 10 units of Straight Ventricular Catheters due to an incomplete packaging seal discovered during final inspection.

    Product
    Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2907-2016·2016-10-12

    Integra Lumbar Drainage Set Recalled for Incomplete Packaging Seal

    Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals discovered during final inspection.

    Product
    Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2910-2016·2016-10-12

    Integra Lumbar Drainage Set Recalled Due to Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.

    Product
    Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2906-2016·2016-10-12

    Integra CUSA Dissectron Fingertip Laparoscopic Cannula Recalled for Packaging Seal Defect

    Integra LifeSciences is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas due to incomplete sterile packaging seals discovered during final inspection.

    Product
    CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2743-2016·2016-09-14

    Integra Recalls Achillon Suture System Due to Sterility Concerns

    Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.

    Product
    Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2600-2016·2016-08-31

    Integra LifeSciences Recalls QWIX Compression Screws Due to Labeling Error

    Integra LifeSciences is recalling QWIX Compression Screws because the product labeling incorrectly identifies them as compression screws rather than positioning screws.

    Product
    Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2387-2016·2016-08-17

    Integra External Fixation System Slotted Post Recall for Breakage During Use

    Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they broke during use at the surgical site.

    Product
    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2386-2016·2016-08-17

    Integra External Fixation System Wire Fixation Bolts Recalled for Breakage

    Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.

    Product
    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2296-2016·2016-08-03

    Integra External Fixation System Rocker Bottom Recall for Loose Silicone Insert

    Integra LifeSciences Corp. is recalling 27 units of the External Fixation System Rocker Bottom because the embedded silicone insert may become dislodged or loose.

    Product
    Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2084-2016·2016-07-06

    Integra LifeSciences Recalls METASURG Capture Screw System K-wires

    Integra LifeSciences is recalling 182 K-wires used in the METASURG Capture Screw System because they do not meet material, surface, and dimensional specifications.

    Product
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2016·2016-07-06

    Integra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error

    Integra LifeSciences is recalling 12 units of the Cadence Size 5 Left Tibial Tray Implant because the outer package label incorrectly identifies the material as Cobalt Chromium instead of Titanium.

    Product
    Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1965-2016·2016-06-22

    Integra Recalls TS Series Depth Gauges for Incorrect Markings

    Integra LifeSciences is recalling 71 TS Series Depth Gauges because some units exceed length specifications or have incorrect millimeter markings.

    Product
    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0025-2016·2015-10-14

    Integra Recalls Universal Compact Head Ring Adapter Plate Due to Assembly Error

    Integra LifeSciences Corp. is recalling six Universal Compact Head Ring Adapter Plates that do not assemble properly due to a manufacturing drawing error.

    Product
    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1815-2015·2015-06-24

    Integra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Catheters because incorrect assembly may allow cerebrospinal fluid or blood to leak.

    Product
    Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapi
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Integra LifeSciences

company in Plainsboro Center, United States

Country
United States
Founded
1989

Official website

Source: Wikidata (Q30283982), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.