Part Number 52-1025; Lot numbers16380-xxxx and 17162-xxxx

Orthopedic Devices

1

No

Nationwide and to one location each in Australia and Spain.

5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. || Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

Part Number 52-1024; Lot numbers16380-xxxx and 17162-xxxx

Orthopedic Devices

1

No

Nationwide and to one location each in Australia and Spain.

4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. || Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

Lot Numbers: 09EHU0028, 09EHU0028A, 10CHU0010, 10CHU0011, 10CHU0032, 10CHU0037, 10CHU0038, 10GHU0005, 10JHU0032, 10LHU0029, 12AHU0013

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.5 MM X 191 MM DRILL, REF 71173806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 09FM13048, 09FM13050, 09HM19220, 09JM05321, 09JM05323A, 10CM17257,  10CM17264, 10CM17267, 10DM13250, 10EM07916, 10FM17121, 10FM19218, 10JM02801, 10JM02804, 10KM03818, 10KM03819, 11AM05484, 11AM15993, 11CM10621, 11EM08614, 11EM08616, 11FM16054, 11KM06137, 11LM04640, 11MM09298

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM TROCAR, REF 71751136, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 06JM08741B, 07GM04922B, 09CM18043, 09HM04046A, 09JM15028, 09JM15029, 09KM15327, 10DM14293, 10DM14294, 10DM14295, 10DM14296, 10DM14297, 10DM14298, 10KM06473, 11AM08963, 11AM08964, 11CM08579, 11CM08581, 11HM15636, 11JM09284, 11KM07815, 11KM07817, 11LM09303, 11LM10342, 11LM10344, 12BM11721

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71780105, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 06HHU0020E, 07HM04821A, 07JHU0008, 08AM10972A, 08KM16567A, 09FM00898,  09FM00899, 09FM00900, 09FM00901, 09FM00902, 09FM00903, 09FM03558, 10AM01791, 10AM01796, 10AM01799, 10AM01803, 10BM04399, 10CM18678, 10CM18680, 10CM18682, 10HM07692, 10HM07789, 10JM07318, 10JM07320, 11AM15222, 11BM09186, 11BM09205, 11DM02807, 11DM02828, 11FM04982, 11FM04985, 11HM18980, 11HM18991, 11KM09348, 11KM09350, 11KM15076, 11KM15077, 12BM08098, 475163-13A, 475163-30B, 475843-15B, 475843-19A, 475843-1B, 475843C, 483936-1B, 485275-4B

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL, REF 71687001, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 06GM12595B, 08CM06783A, 09CM18034, 09CM18034A, 09EM01140, 09EM01141A,  09EM19903, 09EM19906, 09EM19907, 09EM19910A, 09EM19963, 09EM19975, 09GM01874, 09GM01874A, 09GM10893, 09GM10894, 09HM04043, 09HM04044, 09JM13526, 09JM13529, 09JM15025, 09JM15026, 09KM15318, 09KM15320, 09KM15323, 09KM15329, 09KM15807, 09KM15807A, 10DM06041, 10DM06042, 10DM06161, 10DM06162, 10DM06163, 10DM06165, 10DM14300, 10DM14304, 10DM14307, 10DM14310, 10GM08573, 10GM08577, 10GM13126, 10JM11193, 10JM11195, 10JM11197, 10JM11199, 10KM06443, 10KM06448, 10KM06451, 11AM06081, 11AM06082, 11AM06083, 11AM06084, 11AM06087, 11BM10394, 11BM10395, 11BM10396, 11CM08517, 11CM08521, 11CM08530, 11CM08567, 11CM08573, 11DM07718, 11DM07722, 11EM07419, 11EM07421, 11EM07727, 11EM07732, 11GM06594, 11GM06595, 11GM06596, 11GM06711, 11HM15597, 11HM15606, 11HM15611, 11HM15614, 11HM15623, 11JM09277, 11JM09278, 11JM09283, 11KM07809, 11KM07810, 11KM07811, 11KM07812, 11KM07813, 11LM09301, 11LM09302, 11LM10337, 11LM10339, 12BM09921, 12BM09923, 12BM09926, 12BM09929, 12BM09932, 12BM13643, 478052-30A

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71751149, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 09EHU0019, 09EHU0019A, 10BHU0011, 10BHU0012, 10BHU0013, 10BHU0014, 10BHU0017, 10CHU0009, 10CHU0028, 10EHU0012, 10EHU0012A, 10EHU0017, 10EHU0018, 10FHU0014, 10JHU0010

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.7 MM X 191 MM DRILL, REF 71173804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 06DHU0001G, 08AHU0002H, 08AHU0002J, 08AHU0003F, 08EM20830A, 08EM21910A, 08FM01279A, 08FM03803A, 08GM02010A, 08HM00329A, 08HM00329B, 08HM03878A, 08HM08067A, 08KM00141A, 08KM21721A, 08KNG0009B, 08KNG0010B, 08LNG0007A, 08LNG0007B, 08LNG0007C, 08MM15654A, 08MNG0009A, 08MNG0009B, 08MNG0010, 08MNG0010A, 08MNG0011, 08MNG0011A, 09ANG0009, 09ANG0009A, 09ANG0013, 09ANG0013A, 09ANG0013B, 09ANG0014, 09ANG0017, 09ANG0018, 09ANG0018A, 09CM05224, 09CM06262, 09CM07601, 09CM07601A, 09CM08322, 09CM09267, 09CM10095, 09CNG0009A, 09CNG0009B, 09CNG0011, 09CNG0011A, 09CNG0011B, 09CNG0012, 09DNG0001, 09DNG0002A, 09DNG0002B, 09DNG0008, 09DNG0016A, 09DNG0017, 09DNG0018B, 09DNG0018C, 09DNG0019A, 09DNG0021, 09DNG0021B, 09DNG0023D, 09DNG0023E, 09DNG0023F, 09DNG0024, 09DNG0024A, 09DNG0024B, 09FM15589, 09FM15591, 09FM20533, 09FM20534, 09FM20535, 09FNG0006, 09FNG0006A, 09FNG0007, 09FNG0007A, 09FNG0007B, 09FNG0008, 09FNG0008A, 09FNG0008B, 09FNG0008C, 09FNG0011, 09FNG0011A, 09FNG0011B, 09FNG0015, 09FNG0015A, 09FNG0016, 09FNG0016A, 09FNG0017, 09FNG0017A, 09FNG0017B, 09FNG0018, 09FNG0018A, 09FNG0019, 09FNG0019A, 09GNG0014, 09GNG0014A, 09GNG0019, 09GNG0019A, 09GNG0020, 09GNG0020A, 09GNG0021, 09GNG0021A, 09JNG0001, 09JNG0001A, 09JNG0009, 09JNG0009A, 09JNG0011, 09JNG0011A, 09JNG0012, 09JNG0012A, 09JNG0013, 09JNG0013A, 09KM00535, 09KM03546, 09KM04458, 09KM04459, 09KM07958, 09KM07960, 09KM07963, 09MM00182, 09MM00185, 09MM00189, 09MM00196, 09MM08523, 09MM08526, 09MM08527, 09MM08530, 09MM09620, 09MM09622, 09MM09677, 10CM09863, 10CM11010, 10CM11014, 10CM11016, 10CM11017, 10CM11019, 10CM16244, 10CM16246, 10CM16248, 10CM16250, 10HNG0003, 10HNG0006, 10JNG0001, 10JNG0001A, 10JNG0002, 10JNG0002A, 10JNG0003, 10JNG0003A, 10JNG0004, 10JNG0004A, 10KM16333, 10KM16338, 10KM16343, 10KM16349, 10KM16352, 10KM16354, 10KNG0001, 10KNG0001A, 10KNG0002, 10KNG0002A, 10KNG0003, 10KNG0003A, 10KNG0005, 10KNG0005A, 10KNG0005B, 10KNG0006, 10KNG0006A, 10KNG0006B, 10KNG0009, 10KNG0009A, 10LM03223, 10LM03225, 10LM14475, 10LM14479, 10LM14480, 10LNG0014, 10LNG0014A, 10LNG0015, 10LNG0015A, 10LNG0016, 10LNG0016B, 10LNG0017, 10LNG0017A, 10MNG0003, 10MNG0003A, 10MNG0004, 10MNG0004A, 11ANG0001, 11ANG0001A, 11ANG0002, 11ANG0002A, 11ANG0003, 11ANG0003A, 11ANG0003B, 11ANG0009, 11ANG0009A, 11ANG0009B, 11BNG0001, 11BNG0001A, 11BNG0001B, 11BNG0002, 11BNG0002A, 11BNG0002B, 11CNG0001, 11CNG0001A, 11CNG0002, 11CNG0002A, 11CNG0003, 11CNG0003A, 11CNG0004, 11CNG0004A, 11DNG0004, 11DNG0004A, 11DNG0005, 11DNG0005A, 11DNG0006, 11DNG0006A, 11FM08241, 11FM08248, 11FM08249, 11FM08251, 11FM08253, 11FM11401, 11FM11402, 11FM11404, 11FM11405, 11FM11406, 11FM11408, 11FM14237, 11FM14238, 11FM14239, 11FM14240, 11FM14241, 11JM08775, 11JM08776, 11JM08777, 11JM08778, 11JM08779, 11JM08780, 11JM08784, 11JM14603, 11JM14605, 11JM14606, 11JM14607, 11JM16544, 11JM16549, 11JM16551, 11JM16561, 11KM04267, 11KM04269, 11KM04271, 11LM05280, 11LM05284, 11LM05286, 11LM05290, 11LM05295, 11LM05300, 11LM05359, 11LM06178, 11LM06184, 11LM06185, 11LM06194, 11LM09277, 11LM09278, 11LM09280, 11MM05190, 11MM05191, 11MM05193, 11MM05198, 11MM06015, 11MM06782, 11MM06809, 11MM08155, 11MM08157, 11MM08158, 11MNG0001, 11MNG0013, 11MNG0028, 11MNG0032, 12AM05781, 12AM05782, 12AM05783, 12AM05785, 12AM07665, 12AM07667, 12AM07668, 12AM07670, 12AM07671, 12AM07672, 12AM10996, 12AM12030, 12AM13198, 12AM13199, 12AM13200, 12ANG0008, 12BNG0007, 12BNG0007A, 12BNG0008, 12BNG0008A, 4500047794, 4500050285, 477751-32A, 477751BJ, 477808-11A, 477808-2A, 477808-4B, 477808-51B, 477808-53A, 477808-7A, 477808E, 477808J, 480313-15A, 480313-50A, 480313-7A

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.7 MM DRILL BIT, REF 71173503, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 09EHU0011, 09EHU0011A, 10AHU0015, 10AHU0015A, 10AHU0016, 10CHU0021, 10CHU0022, 10CHU0033, 10CHU0046, 10DHU0020, 10EHU0011, 10EHU0019, 10EHU0019X

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.0 MM X 191 MM DRILL, REF 71173802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 07BHU0004E, 07CHU0010E, 07DHU0025D, 07DHU0025E, 07LHU0004J, 07LHU0004K, 07LHU0004L, 07LHU0004M ,08AHU0004J, 08BHU0019G, 08BM20807A, 08CHU0016G, 08CHU0018F, 08FM15736B, 08JHU0008B, 08LHU0020G, 08MHU0026C, 09BHU0031E, 09BHU0031F, 09BHU0031G, 09CHU0044D, 09DHU0019, 09DHU0019B, 09DHU0036, 09DHU0036C, 09DHU0036D, 09DHU0036E, 09DHU0036F, 09EHU0003, 09EHU0003A, 09EHU0003B, 09EHU0003C, 09EHU0003D, 09EHU0003E, 09EHU0003F, 09EHU0007, 09EHU0007A, 09EHU0007B, 09EHU0007C, 09EHU0007D, 09EHU0013, 09EHU0013A, 09EHU0013B, 09EHU0013C, 09EHU0013D, 09EHU0013E, 09EHU0013F, 09FHU0005, 09FHU0005A, 09FHU0033, 09FHU0033B, 09FHU0033C, 09FHU0033D, 09FHU0033F, 09FHU0033G, 09FHU0033H, 09GM06174A, 09GM14035, 09HHU0008, 09HHU0010, 09HHU0010A, 09HHU0010B, 09HHU0010C, 09HHU0010D, 09HHU0010E, 09HHU0010F, 09HM12199, 09HM12202, 09HM17431, 09KHU0001, 09KHU0001A, 09KHU0001B, 09KHU0001C, 09KHU0001D, 09KHU0001E, 09KHU0001G, 09KHU0001H, 09KHU0001P, 09KHU0010, 09KHU0010A, 09KHU0010B, 09LM10792, 09MM01112A, 10AM02971, 10BHU0007, 10BHU0007A, 10BHU0007B, 10BHU0007C, 10BHU0007D, 10BHU0007F, 10BHU0007G, 10BHU0010, 10BHU0010A, 10BHU0010M, 10BHU0018, 10BHU0018A, 0BHU0018B, 10BHU0018C, 10BHU0018D, 10BHU0018E, 10BHU0018F, 10EHU0013, 10EHU0013A, 10EHU0013B, 10FM16220, 11CHU0015A, 11CHU0015B, 11CHU0015C, 11DHU0003, 11DHU0003A, 11DHU0005, 11DHU0005A, 11DHU0005B, 11HHU0027, 11HHU0030, 11HHU0031, 11HHU0031B, 11HHU0032, 11HHU0034, 11JHU0006, 11JHU0007, 11JHU0008, 11JHU0009, 11JHU0010, 11JHU0024, 11JHU0024A, 11KHU0007, 11KHU0016, 11LHU0004, 11LHU0005, 11LHU0005A, 11LHU0007, 11LHU0008, 11LHU0011, 11LHU0011A, 11LHU0012, 11LHU0027, 11LHU0027A, 11LHU0027C, 11LHU0027X, 11LHU0034, 11LHU0035, 11MHU0005, 11MHU0005A, 11MHU0005D, 1MHU0017, 11MM11935, 11MNG0008, 11MNG0008A, 11MNG0008B, 11MNG0009, 11MNG0009A, 11MNG0009C, 11MNG0018, 11MNG0018D, 11MNG0018E, 11MNG0025, 11MNG0025N, 11MNG0025P, 12AHU0001, 12AHU0001B, 12AHU0001C, 12AHU0014, 12BHU0010, 12BHU0010B, 12BHU0011, 12BHU0011A, 12BHU0025, 12BHU0025A, 12BHU0025B, 12BHU0025E, 12BHU0025G, 477420-14A

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.