Recall Z-1685-2013— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2013-02-01, terminated 2013-07-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.. Reason: The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-01
- Terminated
- 2013-07-25
- Firm location
- Plainsboro, NJ, United States
Product description
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Reason for recall
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.