device · product 1 of 1
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.
- Recall number
- Z-1847-2015
- Initiated
- May 26, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 15,798
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Error in labeling
Inspect official wording and provenance
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.
Code information
Correction includes all lots of products distributed between January 2007 and March 2015. P/N: 9734240,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),9730944,4.5 mm Cannulated Tap,9730945,5.5 mm Cannulated Tap,9730946,6.5 mm Cannulated Tap,9733182,4.0 mm Cannulated Tap, 1.86P,9733183,4.5 mm Cannulated Tap,9733184,4 mm Cannulated Tap, 1.5P, UCSS,960-347,7.5 Old Round APT (Cannulated Tap-Tip only),960-345,6.5 Old Round APT (Cannulated Tap-Tip only),960-344,5.5 Old Round APT (Cannulated Tap-Tip only) The above referenced cannulated taps are included in the kits and,9731921,KIT 9731921 INSTRUMENT SPINE BASIC,9735101,INST KIT 9735101 TAP ASM 4.5 G5, 9735102,INST KIT 9735102 TAP ASM 5.5 G5,9735103,INST KIT 9735103 TAP ASM 6.5 G5,9735107,INST KIT 9735107 TAP ASM 5.0 G5,9735108,INST KIT 9735108 TAP ASM 6.0 G5,9735109,INST KIT 9735109 TAP ASM 7.5 G5,9735149,INST KIT 9735149 CANNULATED 6.5MM TAP,9735150,INST KIT 9735150 CANNULATED 5.5MM TAP,9735151,INST KIT 9735151 CANNULATED 4.5MM TAP,9735168,INST KIT 9735168 4MM TAP 1.86P,9735169,INST KIT 9735169 4.5MM CANN TAP,9735170,INST KIT 9735170 4MM TAP 1.5P,9734490,INST SET 9734490 LEGACY,9734491,INST SET 9734491 SOLERA STD,9734492,INST SET 9734492 SOLERA DEF UPGRADE,9735469,TAPS 9735469 CD HORIZON SOLERA,9734631,TD SET 9734631 LEGACY STD TAPS/DRIVERS,9734632,TD SET 9734632 SOLERA STD TAPS/DRIVERS,9733370,VERTEX MAX SET, 9733370, NAVIGATED,9734838,KIT 9734838 SOLERA 8.5 CANNULATED TAP,
Distribution pattern
Worldwide Distribution.