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

Recall Z-1666-2015 — Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

U.S. FDA — Device Enforcement · United States · 2015-04-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1666-2015
Date of alert: 2015-04-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: United Surgical Associates
Product category: device
Product type: Devices

Reported risk: The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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-1666-2015 — Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

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