Recall archive
92 recalls · page 4 of 4
Reported Jun 11, 2014
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide…
FDA (openFDA device enforcement)
Reported May 7, 2014
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.
FDA (openFDA device enforcement)
Reported Feb 26, 2014
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel +…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
FDA (openFDA device enforcement)
Reported Feb 19, 2014
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Reason for recall — Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial…
FDA (openFDA device enforcement)
Reported Jan 15, 2014
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2014
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod…
FDA (openFDA device enforcement)
Reported Jan 1, 2014
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. d.b.a. Integra Pain Management
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit…
FDA (openFDA device enforcement)
Reported Dec 25, 2013
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. d.b.a. Integra Pain Management
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the…
FDA (openFDA device enforcement)
Reported Oct 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2013
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. d.b.a. Integra Pain Management
Matched: Brand · Reason for recall — Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised…
FDA (openFDA device enforcement)
Reported Jul 17, 2013
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
FDA (openFDA device enforcement)
Reported Jul 3, 2013
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Integra LifeSciences Corp.
Matched: Brand — As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the…
FDA (openFDA device enforcement)
Reported Apr 24, 2013
Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using…
FDA (openFDA device enforcement)
Reported Mar 20, 2013
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel +…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA…
FDA (openFDA device enforcement)
Reported Mar 6, 2013
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides…
FDA (openFDA device enforcement)
Reported Feb 27, 2013
MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Integra determined there is a possibility that the Base Units may break during use.
FDA (openFDA device enforcement)
Reported Aug 8, 2012
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
FDA (openFDA device enforcement)
Reported Jul 11, 2012
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Integra LifeSciences Corp. d.b.a. Integra Pain Management
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
FDA (openFDA device enforcement)
Reported Jun 20, 2012
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains…
1 more product in this recall
FDA (openFDA device enforcement)
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