Zimmer Biomet Inc. reported a recall of the EBI Osteogen Implantable Bone Growth Stimulator, the SpF Plus-Mini Implantable Spinal Fusion Simulator (60 A/W) and the SpF-XL IIb 2/DM Implantable Spinal Fusion Stimulator due to lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue, which may cause serious side effects for patients. All serial numbers for these products expiring prior to March 31, 2019 are the devices that are affected.
The stimulators are used to help heal bone following spinal fusion surgery or fractured long bones in a patient with a health condition or other factors that prevents their body from healing bone on its own.
In a press release from the FDA, it was noted health care providers who use these devices and patients who have been implanted with any of these stimulators may be affected by this recall. Zimmer Biomet issued an Urgent Medical Device Recall Notification Letter on Feb. 19, 2018, to all affected customers, which instructed:
- Consignees to return an acknowledgement of responsibilities and inform affected team members of the recall.
- Hospital risk managers to set aside any product for sales representative or distributor pick-up.
- Surgeons to continue monitoring patients who have had one of the affected devices implanted.
- Distributors to quarantine any devices in inventory and send them back to the firm, as well as identify all consignees that have product on-hand, so sales representatives can work with consignees to reconcile all remaining product.
Customers with questions may contact Zimmer Biomet Inc. Adverse reactions or quality problems can be reported to the FDA Safety Information and Adverse Event Reporting Program.