SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation…
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However,…
Read the official notice →- Date
- 2025-12-24
- Country
- United States
- Brand
- Seaspine Orthopedics
- Product
- Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone…
- Classification
- Class II
- Units
- US: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 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 Seaspine Orthopedics recalls
- 2026-09-30
USSEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
The proximal thread depth of the spinal device is out of design specification.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUS Nationwide distribution in the states of Alabama, California, Colorado,…Official notice →- 2026-07-29
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SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - 2025-09-17
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery,…
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONWorldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH,…Official notice → - 2025-01-01
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002…
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONU.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.Official notice → - 2024-07-24
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description:…
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONThe product was distributed to the following US states: Nevada, Colorado,…Official notice → - 2024-07-10
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product…
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUnited States Nationwide distribution in the states of Nevada, Texas,…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-24
- US
DICOM Grid, Inc. recalls Intelerad InteleShare software, with ProViewer component
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction…
FDA · DeviceDICOM Grid, Inc.US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ,…Official notice → - US
PATH recalls MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can…
- US
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
FDA · DeviceInstrumentation LaboratoryDomestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL,…Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
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GE Healthcare GmbH recalls GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
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Datascope Corp. recalls Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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