Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-21

FDA device recall Z-0938-2014 · posted 2014-02-07 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

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.

Action taken

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.

Root cause

Manufacturing material removal

Status

Terminated

Product code

NKB

Quantity affected

40

Distribution

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

Date initiated

2014-01-22

Date posted

2014-02-07

Date terminated

2014-12-17

Location

Plainsboro, NJ

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