Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP50150*

FDA device recall Z-1649-2012 · posted 2012-05-23 · Terminated

Recall details

Recalling firm

Captiva Spine, Inc

Reason for recall

Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime

Action taken

Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels. For questions customers should call 877-772-5571. For questions regarding this recall call 561-277-9480.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KWQ

Quantity affected

105 units

Distribution

Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.

Date initiated

2011-11-22

Date posted

2012-05-23

Date terminated

2013-11-18

Location

Jupiter, FL

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