FDAFDA · Food and drugs·Recall number Z-1832-2013
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Published August 7, 2013 · Recall initiated: May 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
- Lot
- Lot #: 52667001 Catalog #: 181-00-04
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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