FDAFDA · Food and drugs·Recall number Z-0938-2014
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.
Published February 19, 2014 · Recall initiated: January 22, 2014
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
Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.
- Lot
- Model Number(s): 91-2109 (8.0 Plus) 91-2110 (Standard). Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard. The devices are not distributed as sterile and do not have a expiration date.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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