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.
Read the official notice →- Date
- 2024-03-06
- Country
- United States
- Brand
- Alphatec Spine
- Product
- 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…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AL, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 2025-02-05
- US
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 → - 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
- 2024-03-06
- US
EMD Millipore Corporation recalls Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
FDA · DeviceEMD Millipore CorporationDomestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.Official notice → - US
Medagent Inc recalls Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD.…
Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
FDA · DeviceMedagent IncTX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UKOfficial notice → - US
Zyno Medical LLC recalls Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to…
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in…
- US
Medtronic Neurosurgery recalls Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain…
Potential for catheter disconnection from the patient line stopcock connectors.
FDA · DeviceMedtronic NeurosurgeryWorldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldDistribution US nationwide including Puerto Rico, Canada, UAE, and PanamaOfficial notice → - US
Ventec Life Systems, Inc. recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN…
The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions…
FDA · DeviceVentec Life Systems, Inc.U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: JapanOfficial notice →