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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Captiva Spine, Inc
- 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
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