Innovasis, Inc recalls TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to…
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Read the official notice →- Date
- 2024-09-25
- Country
- United States
- Brand
- Innovasis
- Product
- TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Innovasis recalls
- 2026-08-12
USInnovasis, Inc recalls Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent…
Other drugs & medical recalls in the United States
- 2024-09-25
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human…
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH,…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7…
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia…Official notice → - US
UNIMAX MEDICAL SYSTEMS INC recalls 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable…
The tube may fall into the surgical site during the grasping process.
FDA · DeviceUNIMAX MEDICAL SYSTEMS INCUS Nationwide distribution in the states of GA, MO, and PA.Official notice → - US
Btt Health Gmbh recalls Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by…
- US
Carbon Medical Technologies, Inc. recalls BiomarC EX Fiducial Marker System, Catalog Number 040165
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
FDA · DeviceCarbon Medical Technologies, Inc.US Nationwide distribution in the state of TN.Official notice → - US
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d)…
Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a…