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.

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.

Integra LifeSciences initiated this recall by sending recall notification letter to US consignees, delivered by traceable courier service. Non US consignees notified of the recall by either traceable e-mail or facsimile. The letter dated, January 23, 2014, titled "URGENT: VOLUNTARY MEDICAL DEVICE RECALL Integra Malibu Polyaxial Drivers Catalogue Numbers: 91-2109 & 91- 2110", informed customers of the recall and provided product description with codes, picture of the product, advised customers to: Inspect their inventory of Malibu Polyaxial Drivers. - If you have product(s) with a lot number listed on the following page, STOP USING THEM IMMEDIATLY. - If you do not have Drivers with a lot number listed on the following page, you can continue to use them. Customers were also instructed that regardless if they have Drivers with the affected lots, to complete the attached form and return it to Integra as indicated. Customers were instructed to keep a copy of the form for their records., and contact information. Customers with questions were instructed to contact Customers Service at 1-866-942-8698. For questions regarding this recall call 609-275-0500.