FDAClass IINovember 28, 2012

CapLOX II Final Torque Driver recall

CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation…

Why was CapLOX II Final Torque Driver recalled?

Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.

Product
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation…
Recalling firm
Captiva Spine, Inc
Quantity
10
Distribution
Nationwide Distribution (Distributed to one customer located in MN)
Recall date
November 28, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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