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Recall Observatory FDA recall evidence

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Recalled products

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86,536 products

Page 3439 of 3462

Product Firm Event Initiated
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively. Stryker Spine Event 61723 January 13, 2012
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories. Vital Scientific N.V. Event 83582 January 10, 2012
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use Vital Scientific N.V. Event 83582 January 10, 2012
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use Vital Scientific N.V. Event 83582 January 10, 2012
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use Vital Scientific N.V. Event 83582 January 10, 2012
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories. Vital Scientific N.V. Event 83582 January 10, 2012
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium. The Anspach Effort, Inc. Event 63086 January 09, 2012
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium. The Anspach Effort, Inc. Event 63086 January 09, 2012
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium. The Anspach Effort, Inc. Event 63086 January 09, 2012
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. Synthes, Inc. Event 70055 January 06, 2012
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment. Cook Ireland Ltd. Event 61451 January 05, 2012
GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients. GE Healthcare, LLC Event 64748 January 04, 2012
Stewart's Diet Orange N' Cream Soda, 12oz glass bottles Dr Pepper/ Seven Up, Inc Event 61120 January 03, 2012
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients. SpineFrontier, Inc. Event 64989 December 30, 2011
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue. Stryker Howmedica Osteonics Corp. Event 62130 December 29, 2011
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process. Stryker Howmedica Osteonics Corp. Event 61923 December 29, 2011
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000. SpineFrontier, Inc. Event 63145 December 23, 2011
Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Church & Dwight Inc Event 60853 December 22, 2011
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Church & Dwight Inc Event 60853 December 22, 2011
Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Church & Dwight Inc Event 60853 December 22, 2011
Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal Church & Dwight Inc Event 60853 December 22, 2011
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Church & Dwight Inc Event 60853 December 22, 2011
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal Church & Dwight Inc Event 60853 December 22, 2011
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Church & Dwight Inc Event 60853 December 22, 2011
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. Church & Dwight Inc Event 60853 December 22, 2011

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