Medtronic Recalls Navigated Cannulated Taps Due to Cleaning Injury Risk
Medtronic Navigation is correcting 15,798 Navigated Cannulated Taps distributed worldwide due to a potential for injury during the cleaning process.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Medtronic Navigation, Inc. is initiating a field correction for Medtronic Navigated Cannulated Taps. These medical devices are designed for use in spine surgery to assist in the tapping procedure and the placement of screws. The recall covers 15,798 units that were distributed worldwide between January 2007 and March 2015.
The correction is being initiated due to the potential for injury which could occur as a result of cleaning the devices. The source text does not specify the exact nature of the injury or report any specific incidents.
Healthcare facilities and users should refer to the official recall notice for specific instructions on how to handle the affected devices. The correction includes all lots of the referenced products distributed during the specified period.
The recalled product
- Product
- Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled…
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 15,798
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 (20)
- Nav 6.5mm Tap (Cannulated)
- 9734239
- Nav 5.5mm Tap (Cannulated)
- 9734238
- Nav 4.5mm Tap (Cannulated)
- 9734302
- 6.5mm Tap (Cannulated)
- 9734300
- 5.5mm Tap (Cannulated)
- 9734298
- 4.5mm Tap (Cannulated)
- 9734303
- 7.5mm Tap (Cannulated)
- 9734301
- 6.0mm Tap (Cannulated)
- 9734299
- 5.0mm Tap (Cannulated)
- 9734304
- 8.5mm Tap (Cannulated)
- 9730944
Distribution
Distribution scope not specified by the agency.
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