Taps

Model: various, Affected:

md

medical_device

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,

Neurological Devices

2

No

Worldwide Distribution.

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.

Product, Catalog #, Lot #, Expiration Date 1.5MM resorbable cortex screw 3MM-sterile, 800.603.10S, 1373642, 07/2009; 1.5MM resorbable cortex screw 3MM-sterile, 800.603.20S, 1372400, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1384887, 08/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1393224, 09/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2162367, 10/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2175547, 01/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2183488, 02/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.10S, 1371226, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.20S, 1371227, 07/2009; 1.5MM resorbable cortex screw 5MM-sterile, 800.605.10S, 1372687, 07/2009; 1.5MM resorbable cortex screw 6MM-sterile, 800.606.10S, 1373640, 07/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1384577, 08/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1387942, 09/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.10S, 1373751, 07/2009; 2.0MM resorbable cortex screw 4MM-sterile, 801.004.10S, 1374122, 07/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2162368, 10/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2184323, 02/2010; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.10S, 1374135, 07/2009; 2.5MM resorbable emergency screw 8MM-sterile, 801.048.02S, 1384578, 8/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1384602, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1393219, 09/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1372401, 07/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1376216, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1377498, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile,  805.603.20S, 1372402, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2169297, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2180984, 02/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384597, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384598, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 1384599, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392087, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 1392088, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1393230, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 2162401, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163458, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163459, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2164282, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2167890, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 2169299, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175554, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175801, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370038, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370040, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1370041, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375932, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375933, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1376307, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377501, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1377502, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1380682, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385761, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385763, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385764, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1385780, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1388207, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1390841, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1392090, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393233, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1393234, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1370039, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1376219, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1377503, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1378428, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.20S, 1383881, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1390843, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1392089, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2167288, 11/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2181842, 02/2010; 1.5MM rapid resorbable cortex screw 5MM-sterile,  805.605.04S, 1384604, 08/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1392091, 09/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 2167289, 11/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 1374134, 07/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 2175551, 01/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile,  805.606.02S, 1393239, 09/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 2181849, 02/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.04S, 2164288, 10/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 1373641, 07/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 2167291, 11/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile,  805.608.02S, 2171103, 12/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.04S, 2175552, 01/2010; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.04S, 1387950, 09/2009; 1.5MM rapid resorbable tack 4MM-sterile,  805.614.10S, 2165696, 11/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160255, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160256, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1374125, 07/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1377504, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile,  806.006.02S, 2167290, 11/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1384596, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388815, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1385773, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388795, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile,  806.006.10S, 1374136, 07/2009; 2.5MM rapid resorbable emergency screw 4MM-sterile, 806.044.02S, 1392093, 09/2009; 2.5MM rapid resorbable emergency screw 6MM-sterile, 806.046.02S, 2163371, 10/2009.

Dental Devices

2

Yes

Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United States to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, AND WV.

Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.