Bock,Otto,Orthopedic Ind,Inc

Material number 3C85, serial numbers: 200547006, 200547007, 200547008, 200547009, 200547034, 200547035, 200547036, 200547037, 200547038, 200547039, 200548022, 200548023, 200548037, 200548038, 200548039, 200548040, 200548041, 200548042, 200604015, 200604016, 200604017, 200604021, 200604022, 200604024, 200604064, 200605002, 200613003.   Material number 3C95, serial numbers: 200531057, 200531058, 200531059, 200531060, 200547003, 200547004, 200547005, 200547024, 200547049, 200547050, 200547051, 200547052, 200547053, 200547054, 200547055, 200547056, 200547057, 200548007, 200548008, 200548009, 200548010, 200548011, 200548012, 200548013, 200548014, 200548015, 200548016, 200548017, 200548018, 200548019, 200548020, 200548034, 200548035, 200548036, 200548044, 200548045, 200548046, 200548047, 200548048, 200548049, 200548051, 200548052, 200548053, 200548054, 200548055, 200548056, 200548058, 200548059, 200548060, 200548061, 200548062, 200548063, 200548064, 200548065, 200548067, 200548068, 200604001, 200604002, 200604003, 200604004, 200604005, 200604006, 200604007, 200604008, 200604009, 200604010, 200604012, 200604013, 200604014, 200604026, 200604027, 200604028, 200604029, 200604030, 200604032, 200604033, 200604034, 200604035, 200604036, 200604038, 200604039, 200604040, 200604041, 200604042, 200604043, 200604044, 200604045, 200604053, 200604054, 200604055, 200604056, 200604057, 200604058, 200604059, 200604062, 200604063, 200605003, 200605004, 200605005, 200605006, 200605008, 200605009, 200605010, 200605018, 200605019, 200605020, 200605021, 200605022, 200605023, 200605054, 200605055, 200605057, 200605058, 200605059, 200605060, 200605061, 200612015, 200612016, 200612017, 200612018, 200612019, 200612020, 200612021, 200612024, 200612029, 200612045, 200612047, 200612050, 200612051, 200612052, 200612053, 200612054, 200612056, 200613034, 200613035, 200613038, 200613039, 200613041, 200613042, 200613043, 200613044, 200613045, 200613054, 200613055, 200613056, 200613057, 200613061, 200613062, 200613063.

Physical Medicine Devices

2

No

Nationwide.

Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.

all cushions with the following material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.

Physical Medicine Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Bosnia and Herzegovina, Brazil, China, Columbia, Croatia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.

Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.

Physical Medicine Devices

1

No

The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.

Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. || Pediatric Prosthetic Device used by Lower Limb amputees.