The FDA has identified this as a Class I recall the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Products: Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and the SpF-XL Implantable Spinal Fusion Stimulator
· Serial numbers: All serial numbers expiring prior to March 31, 2019 are affected.
· Manufacturing Dates: February 14, 2015 to April 11, 2017
· Distribution Dates: April 29, 2015, to March 31, 2018
· Devices recalled in the U.S: 1,360 units
Reason for Recall
Zimmer Biomet, Inc. is recalling the 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. 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.