EBI Patient Care, Inc. recalls 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion…

Recall date

April 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2119-2017

FDA classification

Class I

Brand / firm

EBI Patient Care, Inc.

Sold / distributed

Nationwide distribution only.

Why it was recalled

Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.