Reported Aug 7, 2013 · Terminated
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
- Lot codes and dates
- Lot #: 52667001 Catalog #: 181-00-04
- Amount recalled
- 57
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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