Medtronic Spine Referencing Instrumentation Recalled for Potential Damage
Medtronic is recalling Spine Referencing Instrumentation because the clamps may be damaged if opened beyond limits, potentially leaving components in the patient.
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 risk of leaving a component in the patient's body, which aligns with the rubric criteria for Severe severity involving significant injury reports or structural defects.
Plain-English summary
Medtronic Navigation, Inc. is recalling 2,051 units of Spine Referencing Instrumentation, specifically the Spinous Process Clamp, Short. The 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 due to a potential for the spinal clamps to be damaged when opened beyond intended limits. This damage could result in the clamp not opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
The affected products are identified by Part Numbers 9734716 and 9734716K. The devices were distributed worldwide, including in the United States and numerous foreign countries. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers should stop using the affected Spine Referencing Instrumentation and contact Medtronic Navigation, Inc. for instructions on how to return or dispose of the devices. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns about the procedure.
The recalled product
- Product
- Spine Referencing Instrumentation, Spinous Process Clamp, Short 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 surger
- 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 9734716
- 9734716K
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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