Recall Z-1189-2016— Zimmer Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Spine, Inc., initiated 2016-02-12, terminated 2016-08-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.. Reason: 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)..
- Recalling firm
- Zimmer Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-12
- Terminated
- 2016-08-11
- Firm location
- Minneapolis, MN, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.