Alphatec Spine, Inc. recalls Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505,…
Complaints have been received regarding post-operative implant collapse.
Read the official notice →- Date
- 2025-02-05
- Country
- United States
- Brand
- Alphatec Spine
- Product
- Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Alphatec Spine recalls
- 2026-07-29
USAlphatec Spine, Inc. recalls SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication…
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of TX, MO, IN.Official notice →- 2026-02-18
- US
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC…
Due a design issue where the navigated array connection geometry is incorrect.
FDA · DeviceAlphatec Spine, Inc.U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO,…Official notice → - 2024-03-06
- US
Alphatec Spine, Inc. recalls IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300…
Due to reports of intraoperative graft bolt implantation breakages.
FDA · DeviceAlphatec Spine, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AZ,…Official notice → - 2023-09-06
- US
Alphatec Spine, Inc. recalls LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and…
Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by…
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA,…Official notice → - 2022-11-16
- US
Alphatec Spine, Inc. recalls Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm,…
Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
Other drugs & medical recalls in the United States
- 2025-02-05
- US
Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central…
FDA · DeviceMurata Vios, Inc.Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the…Official notice → - US
LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description:…
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
FDA · DeviceLivaNova USA, Inc.Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…Official notice → - US
Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult,…
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
FDA · DeviceDraeger Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO,…Official notice → - US
Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- US
CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation…
Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of…
FDA · DeviceCareFusion 303, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin…
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.