Z-1832-2013 Class II Terminated
FDA device recall Z-1832-2013 was initiated by Exactech, Inc. on May 30, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Sep 19, 2013). Affected quantity: 57.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2013
- Initiation Date
- May 30, 2013
- Termination Date
- Sep 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57
Product Description
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Reason for Recall
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.
Distribution Pattern
US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
Code Information
Lot #: 52667001 Catalog #: 181-00-04
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1832-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026