Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage
Medtronic Navigation is recalling Spine Referencing Instrumentation sets due to a risk that clamps may break during use, potentially leaving components in the patient's body.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a risk of leaving a component in the patient's body, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Medtronic Navigation, Inc. is recalling Spine Referencing Instrumentation sets, which include spinous process clamps. These devices are intended to provide rigid attachment between the patient and a patient reference frame when used with a Medtronic StealthStation Navigation System during surgery. The recalled units are identified by part numbers 9734715 and 9734716.
The recall is being issued because the spinal clamps may be damaged if opened beyond their intended limits. This damage can result in the clamps not opening once attached to a patient's spinous process or breaking, which could leave a component behind in the patient's body. The recall covers 2,051 units distributed worldwide, including in the United States and numerous foreign countries.
Healthcare facilities and users of these devices should stop using the affected Spine Referencing Instrumentation sets and contact Medtronic Navigation for further instructions on the recall process.
The recalled product
- Product
- Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for th
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 2,051
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)
- P/N 9734715
- 9734716
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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