Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage
Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 constitutes a significant injury risk.
Plain-English summary
Medtronic Navigation, Inc. is recalling 2,051 units of Spine Referencing Instrumentation, Double Spinous Process Clamp, Short (P/N 9734724, 9734724K). 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 devices are intended to be reusable.
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 units were distributed worldwide, including in the United States and various foreign countries. Healthcare providers should stop using the affected devices and contact Medtronic Navigation, Inc. for further instructions.
The recalled product
- Product
- Spine Referencing Instrumentation, Double 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…
- 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 9734724
- 9734724K
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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