FDANovember 10, 2022device
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
What to do
FDA enforcement status: Ongoing
Brands named
nuvasive
UPCs
887517424204887517424211887517426277887517426284887517434210887517434227
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPrecice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Pirifor...2024-09-30
- FDANUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2...2022-11-01
- FDANuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US2022-07-19
- FDADescription/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplif...2022-06-20
- FDANUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CA...2021-10-29
- FDANUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged...2021-02-12
- FDANUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, h...2021-02-12
- FDAPRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.2021-02-12
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