FDA Device recall Z-1189-2016
Universal Clamp¿ System (IFU reference: SNA027-N-90001)
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of Universal Clamp¿ System (IFU reference: SNA027-N-90001) by Zimmer Spine, citing 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: 046W….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1189-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-12 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Spine |
| Distribution | US |
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).
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2016%22
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