Device Recall T2

1806-4280S T2 4.2mmx130mm AO Drill Bit --  K410511; K419243; K419247; K462304; K462306; K579531; K591907; K591914; K591927; K591937; K637448; K713209; K713210; K723426; K737377; K743644; K770908; K776715; K776716; K776717; K776720; K776721; K796725; K796726; K823858; K823859; K823860; K823861; K834973.

Orthopedic Devices

1

No

Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.

T2 4.2mmx130mm AO Drill Bit

Lot Numbers:  000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978

Immunology and Microbiology Devices

2

No

Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.

T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). || A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.

GAM Kirschner Wire - Manufacturing Part Number 12106450S, Lot #'s K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0, K081720, K081721, K0810872, K081723, K081727, K082C8B, K084F89, K084F98, K08683D, K08683E, K086841, K08820B, K089AF5, K08E1E1, K0911F4, K09379B, K096A26, K096A2A, K09A2C, K098213, K098215, K099AA0, K09AD33, K09BA4F, K09D564, K09F026, K0A1EF8, K0A1EFA, KoA1EFB, K0A38FB, K0A63AB, K0A63AC and K0A7BC1  T2 K-Wire - Manufacturing Part Number 18060050S, Lot #'s K084FBF, K0920A4, K0A1EFD, K093747, K0937C4, K09BA53, K09BA54, K09BA55 and K09BA56  T2 K-Wire Recon - Manufacturing Part Number 18063030S, Lot #'s K086847, K08E1E9 and K099AA8

Orthopedic Devices

2

Yes

Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R || Intended for the temporary stabilization of bone segments or fragments

1806-4285S T2 4.2mmx130mm Tri Flat Bit --  K727627; K727628; K727630; K823224; K823225; K824691; K824692; K824693.

Orthopedic Devices

1

No

Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.

T2 4.2mmx130mm Tri Flat Bit

1806-3550S T2 3.5x130mm AO Drill Bit -- K561203; K569685; K569686; K591212; K591213; K653373; K713876; K725975; K743641; K743642.

Orthopedic Devices

1

No

Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.

T2 3.5x130mm AO Drill Bit