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[Enforcement] TriMed Inc. — TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, c

Oct 16, 2019
Published: 2019-10-16Captured: 2026-02-09TriMed Inc.Product: 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 Tr...

FDA issued a Class II enforcement action. Affects TriMed Inc.. Reason: Modifications to the specification were not appropriately qualified through the company's design control process which m.

  • •Classification: Class II
  • •Firm: TriMed Inc.
  • •Status: Terminated
  • •Distribution: Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made t...
Reason

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.

Status:Terminated
Distribution

Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.

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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. | TrueMedDevice