Medtronic Spine Referencing Instrumentation Recalled for Potential Damage
Medtronic Navigation is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall units due to a risk of component breakage or damage during use.
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 is classified as FDA Class II and involves a structural defect in a medical device that could result in a component being left in a patient's body, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Medtronic Navigation, Inc. is recalling 2,051 units of Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall (P/N 9734723, 9734723K). These devices are intended to provide rigid attachment between the patient and the patient reference frame during surgery when used with a Medtronic StealthStation Navigation System.
The recall is issued because the spinal clamps have the potential to be damaged when opened beyond intended limits. This damage may occur either by not opening the clamp once it is attached to a patient's spinous process or by leaving a component behind in the patient's body following breakage.
The affected units were distributed worldwide, including in the United States and numerous foreign countries. Healthcare facilities should stop using these devices and contact Medtronic Navigation for instructions on how to return them.
The recalled product
- Product
- Spine Referencing Instrumentation, Double Spinous Process Clamp, 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 the duration of the
- 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 9734723
- 9734723K
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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