Home / Recalls / Medical Devices
Zimmer Spine, Inc. recalls Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and he
Recalled March 30, 2016 · FDA recall Z-1189-2016 · Zimmer Spine
Hazard
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). · FDA Class II
Units
3484
Sold at
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.
Description
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).
Product
Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
Manufacturer(s)
Zimmer Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →