Belgrade, MT, United States
XTANT Medical recalls
5 recalls recorded since 2018, most recently on 29 December 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 29 December 2021
- Terminated
- 17 June 2024
- Reason
- The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
- Distribution
- U.S.: CA, MI, NV, and TX O.U.S.: Portugal
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0533-2022
- X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Terminated Class III Medical devices
- Recall started
- 30 September 2020
- Terminated
- 21 May 2021
- Reason
- Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
- Distribution
- US: FL, TX, CA, OH, AZ, OH OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0429-2021
- XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X098
Terminated Class II Medical devices
- Recall started
- 12 May 2020
- Terminated
- 19 March 2021
- Reason
- The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
- Distribution
- AZ, TX and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2500-2020
- Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Terminated Class II Medical devices
- Recall started
- 3 May 2019
- Terminated
- 17 December 2020
- Reason
- 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.
- Distribution
- US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1526-2020
- OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indica
Terminated Class II Medical devices
- Recall started
- 19 December 2018
- Terminated
- 1 April 2021
- Reason
- 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.
- Distribution
- US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0790-2019
- Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.