Zimmer Biomet recalls spinal fusion products: 5 things to know

Written by Laura Dyrda | November 27, 2018 | Print  |

Zimmer Biomet recalled the EBI Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator and SpF-XL 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," according to the FDA.

 

Here are five things to know:

1. The products were manufactured from Feb. 14, 2015, to April 11, 2017, and distributed through March 31, 2018. The serial numbers expiring prior to March 31, 2019, are affected.

2. Healthcare providers who used the products and patients who received the products may be affected by the recall. The FDA reported the lack of validation controls could put patients at risk for side effects, including infection, tissue death and the need for additional surgery that would treat wounds or include device removal.

3. In February, Zimmer Biomet issued an urgent medical device recall notification letter to customers on the issue. There were 1,360 units recalled in the U.S.

4. The FDA classified the recall as a Class I recall, meaning use of the devices could cause serious injury or death.

5. The devices were used to help bone healing after spinal fusions or in other situations where individuals with broken long bones were unable to heal without assistance. The stimulators were placed during surgery and delivered a low-level electrical signal to encourage natural bone healing.

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