The Recall Desk
HighFDA (Devices)·Z-0413-2013·Announced 2012-11-28

Captiva Spine Recalls CapLOX II Final Torque Driver Due to Premature Breakage

Captiva Spine is recalling 10 units of the CapLOX II Final Torque Driver because the device may break prematurely during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural failure (premature breaking) of a medical device used in spinal surgery, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Captiva Spine, Inc. is recalling 10 units of the CapLOX II Final Torque Driver, Indicator. This device is part of the CapLOX II Spinal System, a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The recall is being conducted because the device may break prematurely.

The affected units are identified by Model # 2201-5004 and Lot # 06110093. The devices are also serialized as 101-110. The recall is classified as Class II by the FDA. The products were distributed nationwide to one customer located in Minnesota.

Healthcare providers and patients should stop using the affected devices and contact Captiva Spine, Inc. for further instructions on how to proceed with the recall.

The recalled product

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 system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fu
Manufacturer
Captiva Spine, Inc
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Captiva Spine, Inc

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Same hazard · structural failure

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