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Terminated

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 and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.

FDA Recall Z-1847-2015 · Posted 2015-06-26

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2015-05-26
Date Terminated2015-10-23
Product Quantity15,798

Reason for Recall

Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps.

Firm Action

Consignees were notified via Urgent Medical Device Correction Notification on 5/26/15. The letter identified the affected product and described the issue. This field correction does not require the return of the subject products. Revised instructions for use are being provided to the identified consignees.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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