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

Recall Z-0118-2020 — TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.

U.S. FDA — Device Enforcement · United States · 2018-08-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0118-2020
Date of alert: 2018-08-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: TriMed Inc.
Product category: device
Product type: Devices

Reported risk: Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.

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-0118-2020 — TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.

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