THOR

Part Number: 65-2053, Lot Number: 047247.

Orthopedic Devices

2

Yes

Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.

Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. || Intended to promote fusion of the cervical spine and occipitothoracic junction.

a) North American units manufactured between 12/4/09 and 5/16/10 and had a working AEC button, but the manual stated that it was disabled: serial numbers 1863844, 1950710, 1950714, 1954576, 1954577, 1954578, 1954579, 1954581, 1954582, 1954583, 1954584, 1954585, 1954587, 1954589, 1954590, 1954591, 1954593, 1954598, 1954599, 1954600, 1954601, 1954603, 1954605, 1954606, 1954607, 1954614, 1954616, 1954617, 1954618, 1954619, 1954622, 1954623, 1954625, 1954626, 1954627, 1954628, 1954629, 1954630, 1954631, 1954632, 1954633, 1954634, 1954635, 1954637, 1954638, 1954639, 1954640, 1954641, 1954642, 1954643, 1954644, 1954645, 1954646, 1954647, 1954648, 1954649, 1954650, 1954651, 1954652, 1954653, 1954654, 1954656, 1954657, 1954658, 1954659, 1954660, 1954661, 1954662, 1954664, 1954665, 1954666, 1954667, 1954668, 1954669, 1954670, 1954673, 1954674, 1954675, 1957474, 1957926, 1957927, 1957929, 1957930, 1957931, 1957932, 1957933, 1957934, 1957935, 1957936, 1957937, 1957940, 1957941, 1957942, 1957943, 1957944, 1957945, 1957946, 1957947, 1957948, 1957949, 1957950, 1957951, 1957952, 1957953, 1957955, 1957956, 1957959, 1957960, 1957963, 1957966, 1957967, 1957968, 1957973, 1957977, 1957978, 1957980, 1957982, 1957983, 1957983, 1957986, 1957987, 1957988, 1957989, 1957991, 1957994, 1957997, 1957998, 1957999, 1958000, 1958003, 1958004, 1958005, 1958006, 1958007, 1958010, 1958011, 1958012, 1958013, 1958014, 1958015, 1958016, 1958017, 1958018, 1958020, 1958021, 1958022, 1958024, 1958025, 1960071, 1960072, 1960073, 1960074, 1961209, 1961210, 1961218, 1961219, 1961226, 1961231, 1961233, 1961234, 1961236, 1961237, 1961243, 1961244, 1961246, 1961247, 1961248, 1961250, 1961253, 1961255, 1961256, 1961257, 1961258, 1961261, 1961263, 1961264, 1961267, 1961268, 1961269, 1961270, 1961271, 1961272, 1961273, 1961274, 1961275, 1961279, 1961280, 1961283, 1961288, 1961289, 1961290, 1961291, 1961293, 1961294, 1961296, 1961298, 1961299, 1961300, 1961306, 1961307, 1963607, 1963608, 1963611, 1963712, 1963713, 1963714, 1963716, 1963717, 1963718, 1963719, 1963720, 1963721, 1963722, 1963725, 1963726, 1963735, 1963737, 1963738, 1963739, 1963740, 1963741, 1963742, 1963743, 1963744, 1963745, 1963746, 1963747, 1963753, 1963756, 1963758, 1963759, 1963760, 1963766, 1963776, 1963810, 1963812, 1963813, 1963814, 1963816, 1963818, 1963819, 1963820, 1963821, 1963822, 1963823, 1963825, 1963826, 1963827, 1963828, 1963830, 1963831, 1963832, 1963833, 1963835, 1963836, 1963837, 1963838, 1963839, 1963840, 1963842, 1963843, 1963848, 1963849, 1963852, 1963853, 1963855, 1963858, 1963860, 1963876, 1963879, 1963883, 1963886, 1963887, 1963888, 1963895, 1963896, 1963898, 1963899, 1963900, 1963902, 1963904, 1963906, 1963909, 1963910, 1964843, 1964845, 1964846, 1970570, 1970571, 1970572, 1970575, 1970576, 1970577, 1970578, 1970580, 1970583, 1970587, 1970606, 1970608, 1970611, 1970612, 1970613, 1970614, 1970615, 1970618, 1970620, 1970621, 1970622, 1970624, 1970625, 1970627, 1970628, 1970629, 1970630, 1970631, 1970632, 1970634, 1970635 and 1970636;  b) units manufactured between 5/17/10 and 11/9/10 and had a disabled AEC button, but the English section of the international manual stated that it was functional: serial numbers 1957969, 1957971, 1957974, 1961227, 1961228, 1961260, 1961262, 1961276, 1961278, 1961282, 1961284, 1961285, 1961292, 1961302, 1961303, 1961304, 1961305, 1963723, 1963727, 1963729, 1963750, 1963751, 1963752, 1963754, 1963755, 1963757, 1963762, 1963763, 1963765, 1963767, 1963768, 1963769, 1963774, 1963778, 1963782, 1963783, 1963784, 1963785, 1963788, 1963789, 1963790, 1963791, 1963792, 1963794, 1963795, 1963796, 1963800,  1963803, 1963804, 1963806, 1963808, 1963809, 1963815, 1963861, 1963862, 1963864, 1963870, 1963871, 1963872, 1963877, 1963882, 1963884, 1963894, 1963897, 1963908, 1970568, 1970569, 1970573, 1970574, 1970584, 1970586, 1970589, 1970591, 1970594, 1970595, 1970597, 1970598, 1970599, 1970600, 1970601, 1970603, 1970610, 1970616, 1970619, 1970623 and 1970626;  c) units manufactured between 5/17/10 and 11/9/10 and had a disabled AEC button, but the French, German, Italian and Spanish sections of the international manual stated that it was functional: serial numbers 1970638, 1970639, 1970640, 1970641, 1970643, 1970645, 1970649, 1970650, 1970651, 1970652, 1970653, 1970654, 1970663, 1970664, 1973813,  1973814, 1973817, 1973820, 1973824, 1973828, 1973834, 1973848, 1973849, 1973850, 1973851, 1973857, 1973858, 1973878, 1973885, 1973887, 1973889, 1973891, 1973893, 1974792, 1976592, 1976594, 1976598, 1976611, 1976614, 1976619, 1976634, 1976637, 1976638, 1978213, 1978217, 1978221, 1978228, 1978233, 1978252, 1978253, 1978254, 1978255, 1978258, 1978264, 1978265, 1978266, 1978268,  1978269, 1978271, 1978278, 1978279, 1978280, 1978284, 1978285, 1978287, 1978288, 1978289, 1978290, 1978291, 1978292, 1978294, 1978295, 1978296, 1978297, 1978298, 1978299, 1978300, 1978301, 1978302, 1978306, 1978307, 1978308, 1978340, 1978341, 1978342, 1978346, 1978348, 1978350, 1982523, 1982543, 1982552, 1982553, 1982554, 1982561, 1982567, 1982570, 1982571, 1982572, 1982573,  1982575, 1982576, 1982577, 1982578, 1982580, 1982581, 1982582, 1982588, 1982589, 1982590, 1982591, 1982592, 1982593, 1982595, 1982596, 1982597, 1982598, 1982599, 1982601, 1982604, 1982607, 1982608, 1982609, 1982612, 1982614, 1982615, 1982616, 1982617, 1982618, 1982619, 1982621, 1982622, 1982624, 1982625, 1982628, 1982629, 1982631, 1982632, 1982633, 1982634, 1982714, 1982716,  1989268, 1989272, 1989275, 1989276, 1989278, 1989281, 1989293, 1989294, 1989295, 1989298, 1989303, 1989306, 1989307, 1989314, 1989315, 1989316, 1989328, 1989331, 1989339, 1989340, 1989389, 1989395, 1989396, 1989400, 1989401, 1989403, 1989406 and 1989407

Radiology Devices

2

No

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, and WI and the countries of Australia, Canada, Germany, New Zealand, Taiwan, and Vietnam.

Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) || The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.

Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3 and all serial numbers .

Radiology Devices

2

No

Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.

Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. || The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

Part numbers 9869-401-02401, 9869-401-02501, 9869-401-02601, 9869-401-02701, 9869-401-02801, 9869-401-02901, and all serial numbers.

Radiology Devices

2

No

Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.

Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. || The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.

Cardiovascular Devices

3

Yes

International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.

Valiant Thoracic Stent Graft with Captivia Delivery System, || Talent Thoracic Stent Graft with the Captivia Delivery System.