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Sources: EU EUDAMED, US FDA
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Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.
FDA Enforcement
Class II
·Terminated·Biomet Spine, LLC·March 4, 2015
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
FDA Enforcement
Class II
·Terminated·Biomet Spine LLC.·November 26, 2014
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
FDA Recall
Terminated
·Elite Biomedical Solutions LLC·Product code FRN·June 3, 2015
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
FDA Recall
Terminated
·Elite Biomedical Solutions LLC·Product code FRN·June 3, 2015
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Recall
Terminated
·Smisson-Cartledge Biomedical, LLC·Product code LGZ·February 18, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Recall
Terminated
·Smisson-Cartledge Biomedical, LLC·Product code LGZ·February 18, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Recall
Terminated
·Smisson-Cartledge Biomedical, LLC·Product code LGZ·February 18, 2021
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
FDA Enforcement
Class II
·Terminated·Biomet Spine, LLC·February 18, 2015
K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
FDA Recall
Terminated
·Kamiya Biomedical Company, LLC·Product code MGA·September 17, 2008
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code LRO·July 22, 2013
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·June 25, 2014
"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***" Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NSQ·February 23, 2010
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·May 31, 2012
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Gingihue 15 degree Pre- Angled Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Conical EP Pick-Up Coping (Non-Hexed) Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Locator Abutment Impression Coping Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Gingihue Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015