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,…
Read the official notice →- Date
- 2025-09-17
- Country
- United States
- Brand
- Seaspine Orthopedics
- Product
- Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Seaspine Orthopedics recalls
- 2026-09-30
US
SEASPINE 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
US
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 →- 2025-12-24
US
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,…
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUS: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ,…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
- 2025-09-24
US
- 2025-09-17
US
Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Failure of fusion system instruments in the field.
FDA · DeviceOmnia MedicalUS Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.Official notice →US
Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the…
US
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329…
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY,…Official notice →US
Quest International, Inc. recalls Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software…
Measles IgM Test Kit lacks premarket approval or clearance.
FDA · DeviceQuest International, Inc.US Nationwide distribution in the states of Utah, Texas, and Arizona.Official notice →US
Boston Scientific Corporation recalls ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02,…
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide and the countries of Canada, France, Germany and…Official notice →