FDAMarch 22, 2024device
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
What to do
FDA enforcement status: Ongoing
Brands named
ebi
UPCs
00812301020218
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABiomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 10677182024-03-22
- FDA20" Lead Wires, Replacement Part Number: 1067724-22024-03-22
- FDA48" Lead Wires, Replacement Part Number: 1067724-42024-03-22
- FDA10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.2017-04-20
- FDA10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.2017-04-20
- FDACypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adju...2014-10-08
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →