The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-3141-2017·Announced 2017-09-27

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.

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 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.
Category
Medical Device — Surgical Instrumentation
Hazard
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

Distributed in 44 states:

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.

See all 5 products in this recall →

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