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# Class 1 Recall for Zimmer Spinal Fusion Stimulators
- URL: https://www.fdaweb.com/class-1-recall-for-zimmer-spinal-fusion-stimulators/
- Published: 2018-11-27T12:00:00.000Z
- Updated: 2026-09-15T00:46:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142896

FDA has classified as Class 1 a Zimmer Biomet recall of its EBI Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini (60 μA/W) Implantable Spinal Fusion Stimulator, and the SpF-XL IIb 2/DM Implantable Spinal Fusion Stimulator due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue. An FDA [recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm626704.htm?ref=fdaweb.com) says that the “lack of adequate validation and controls may or may not cause serious side effects for the patient including infection, tissue death, additional surgery for wound treatment and/or device removal, impaired wound and bone healing, the need for long-term antibiotic therapy, the potential for secondary gastroenteritis, swelling and infection around the spinal cord (epidural abscess), paralysis, damage to other organs or death.”

The notice says 1,360 devices are affected, including all device serial numbers expiring prior to 3/31/2019\. Affected devices were manufactured between 2/14/2015 and 4/11/2017.