Zimmer Spine, Inc. recalls Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and help…

Recall date

February 12, 2016

Source

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

Recall number

Z-1189-2016

FDA classification

Class II

Brand / firm

Zimmer Spine, Inc.

Sold / distributed

US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.

Why it was recalled

Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.