Z-1832-2013Class II

Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue...

Name: Z-1832-2013 Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue...
Creator: Exactech, Inc.
Published: 2013-05-30
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2013-05-30 / Terminated

FDA source

Exactech, Inc. began a recall of Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic... on 2013-05-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1832-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Posted: 2013-07-31
Terminated: 2013-09-19
Recalling firm: Exactech, Inc.
Product: Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Product code: GFC Driver, Surgical, Pin
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.
FDA root cause: Under Investigation by firm
Action: Exactech sent a" Important Product Recall Notice" dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to Immediately cease distribution or use of the products. Extend this information to your accounts that may have this product in their possession. Verify if you have any of the subject ARTICULATE DRIVER (catalog number 181-00-04) in the specified lots. FAx back the attached form. Further questions please call 1-800-392-2832.
Quantity in commerce: 57
Distribution: US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
Product codes and lots: Lot #: 52667001 Catalog #: 181-00-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1832-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1832-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-31

Product code GFC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)