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

Recall Z-0776-2014 — Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach t

U.S. FDA — Device Enforcement · United States · 2013-09-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0776-2014
Date of alert: 2013-09-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: SpineFrontier, Inc.
Product category: device
Product type: Devices

Reported risk: Handles and heads may not be compatible.

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.

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