Z-0938-2014Class II

Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model...

Name: Z-0938-2014 Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model...
Creator: Integra LifeSciences Corp.
Published: 2014-01-22
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-01-22 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2014-01-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0938-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-22
Posted: 2014-02-07
Terminated: 2014-12-17
Recalling firm: Integra LifeSciences Corporation
Product: 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: 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.
Quantity in commerce: 40
Distribution: Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0938-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0938-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-07

Product code NKB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)