FDA Device Recalls

Class IITerminated

LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 6.5mm x 35mm; f. 6.5mm x 40mm; g. 6.5mm x 45mm; h. 6.5mm x 50mm; i. 6.5mm x 55mm; j. 7.5mm x 35mm; k. 7.5mm x 40mm; l. 7.5mm x 45mm; m. 7.5mm x 50mm; n. 7.5mm x 55mm; o. 8.5mm x 35mm; p. 8.5mm x 40mm; q. 8.5mm x 45mm; r. 8.5mm x 50mm; s.8.5mm x 55mm; t. 9.5mm x 35mm; u. 9.5mm x 40mm; v. 9.5mm x 45mm; w. 9.5mm x 50mm; x. 9.5mm x 55mm; Used in spinal fixation surgery.

Integrity Implants Inc.

Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

January 27, 2022 · DeviceView details →

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

CoolSeal Generator, REF: CSL-200-50

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614

Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024

Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

LINQ II Insertable Cardiac Monitor

BUTLER Clear Dip, 12 bottles/case

HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070

Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT

Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT

CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format