CLASS II Device recall · Reported 19 Feb 2014 · FDA Enforcement Report

Malibu Polyaxial Screwdriver, 8.0 Plus recalled by Integra LifeSciences

Integra LifeSciences is recalling Malibu Polyaxial Screwdriver, 8.0 Plus, distributed in 11 states. The recall was initiated on 22 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled40

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0938-2014
FDA event ID: 67350
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 22 Jan 2014
FDA classified: 7 Feb 2014
Reported: 19 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

22 Jan 2014	Recall initiated by company
7 Feb 2014	Classified by FDA	+16 days
19 Feb 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.

Arizona California Florida Iowa Illinois Louisiana Maryland North Carolina New Mexico Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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