Medtronic Spine Referencing Clamp Recall for Potential Breakage
Medtronic is recalling Spine Referencing Instrumentation clamps due to a risk of breakage that could leave 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 components in a patient's body, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
Medtronic Navigation, Inc. is recalling 2,051 units of Spine Referencing Instrumentation, specifically the Spinous Process Clamp, Tall. These devices are intended to be used with the Medtronic StealthStation Navigation System to provide rigid attachment between the patient and the patient reference frame during surgery. The clamps are designed to be reusable and provide bony fixation through single or double spinous process styles.
The recall is being issued because the spinal clamps have the potential to be damaged when opened beyond their intended limits. This damage could result in the clamp not opening once attached to a patient's spinous process, or it could cause the clamp to break, leaving a component behind in the patient's body.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. The specific product codes involved are P/N 9734715 and 9734715K. Healthcare facilities and users should stop using these specific clamps and contact Medtronic for further instructions on the recall.
The recalled product
- Product
- Spine Referencing Instrumentation, 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 surgery
- 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
- 9734715K
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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