🔍 RecallPedia
🔪

Surgical Instruments

🏥 Medical Devices • 6,839 recalls

SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.

SpineFrontier

Class I - Dangerous

The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.

Mar 5, 2015 Surgical Instruments Nationwide View Details →

OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

OriGen Biomedical

Class I - Dangerous

Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.

Mar 30, 2015 Surgical Instruments Nationwide View Details →

Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Bard Peripheral Vascular

Class I - Dangerous

Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.

Mar 17, 2015 Surgical Instruments Nationwide View Details →

Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.

Integra LifeSciences

Class I - Dangerous

A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).

Mar 13, 2015 Surgical Instruments View Details →
← Back to All Medical Devices Recalls