XTANT Medical Recalls
6 recalls on record · May 3, 2017 to February 9, 2022 · Medical Devices
Recalls by year
17
19
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
February 9, 2022Medical DevicesFDA
XTANT Medical recalls X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Hazard: The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
November 18, 2020Medical DevicesFDA
XTANT Medical recalls XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Re
Hazard: Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
July 15, 2020Medical DevicesFDA
XTANT Medical recalls Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Hazard: The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
March 25, 2020Medical DevicesFDA
XTANT MEDICAL INC recalls OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(
Hazard: The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
February 6, 2019Medical DevicesFDA
XTANT MEDICAL INC recalls Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, RE
Hazard: This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.
May 3, 2017Medical DevicesFDA
XTANT MEDICAL INC recalls 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piec
Hazard: The material type on the label may incorrectly state Ti6Al-4V ELI . The rods are composed of Cobalt Chromium.