Z-1189-2016 Class II Terminated
FDA device recall Z-1189-2016 was initiated by Zimmer Spine, Inc. on February 12, 2016 and is designated Class II. Reason for recall: 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 Universa… The recall status is terminated (terminated August 11, 2016). Affected quantity: 3484.
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2016
- Initiation Date
- February 12, 2016
- Termination Date
- August 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3484
Product Description
Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
Reason for Recall
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).
Distribution Pattern
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.
Code Information
All lots