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…
Read the official notice →- Date
- 2023-09-06
- Country
- United States
- Brand
- Alphatec Spine
- Product
- LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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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
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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 → - 2025-02-05
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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.
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL,…Official notice → - 2024-03-06
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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 → - 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
- 2023-09-06
- US
Olympus Corporation of the Americas recalls Visera Hysterovideoscope Olympus HYF Type V
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
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Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
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Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
FDA · DeviceSiemens Healthcare Diagnostics IncUS distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl…
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2),…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay VietnamOfficial notice → - US
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