Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1189-2016 — Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.

U.S. FDA — Device Enforcement · United States · 2016-02-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1189-2016
Date of alert: 2016-02-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Spine, Inc.
Product category: device
Product type: Devices

Reported risk: 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).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1189-2016 — Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.

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