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Sources: EU EUDAMED, US FDA
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Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
FDA Recall
Terminated
·Custom Spine, Inc.·Product code NKB·March 28, 2013
PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints.
FDA Recall
Terminated
·Interventional Spine Inc·Product code HXX·February 3, 2011
Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe.
FDA Recall
Terminated
·Interventional Spine Inc·Product code HXX·February 3, 2011
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWP·July 6, 2011
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWQ·April 10, 2015
PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.
FDA Recall
Terminated
·Interventional Spine Inc·Product code HXX·February 3, 2011
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021