Recall archive
92 recalls · page 3 of 4
Reported Sep 28, 2016
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit…
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 LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie…
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
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 has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are…
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility…
FDA (openFDA device enforcement)
Reported Sep 7, 2016
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
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 recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of…
FDA (openFDA device enforcement)
Reported Aug 31, 2016
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
FDA (openFDA device enforcement)
Reported Aug 17, 2016
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2016
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
FDA (openFDA device enforcement)
Reported Jul 6, 2016
K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2016
TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length…
FDA (openFDA device enforcement)
Reported Jun 8, 2016
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 4, 2015
Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone…
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 received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is…
FDA (openFDA device enforcement)
Reported Oct 14, 2015
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product details · Reason for recall — Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the…
FDA (openFDA device enforcement)
Reported Jul 15, 2015
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet,…
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 Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging…
FDA (openFDA device enforcement)
Reported Jun 24, 2015
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino…
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 is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled.…
FDA (openFDA device enforcement)
Reported May 27, 2015
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen…
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 is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 6, 2015
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet,…
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 — A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
FDA (openFDA device enforcement)
Reported Apr 22, 2015
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance…
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Reason for recall — Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2014
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
FDA (openFDA device enforcement)
Reported Nov 19, 2014
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2014
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/…
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 is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have…
FDA (openFDA device enforcement)
Reported Jul 23, 2014
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
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 is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR…
FDA (openFDA device enforcement)
Reported Jul 9, 2014
MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm);…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Reason for recall — Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2014
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone…
FDA (openFDA device enforcement)
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