Reported Feb 19, 2014 · Terminated
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number…
Integra LifeSciences Corp.
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: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Model Number(s): 91-2109 (8.0 Plus) 91-2110 (Standard). 2 Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. 3 Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. 4 Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard. The devices are not distributed as sterile and do not have a expiration date. - Amount recalled
- 40
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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