Joint, Knee, External Limb Component
Physical Medicine · 21 CFR 890.3420
Recent MDR events
494 adverse event reports on file
- Genium X3Jul 29, 2026MalfunctionOtto Bock Healthcare Products Gmbh9615892-2026-00016
- LOCK LEVERJul 9, 2026InjuryOttobock Se & Co. Kgaa9616494-2026-00004
- BRAINROBOTICS KNEURO MICROPROCESSOR KNEEJul 2, 2026InjuryBrainportfolio Inc3030413824-2026-00001
- GENIUM X3Jul 1, 2026MalfunctionOtto Bock Healthcare Products Gmbh9615892-2026-00015
- GENIUMJun 30, 2026MalfunctionOtto Bock Healthcare Products Gmbh9615892-2026-00013
- GENIUM X3Jun 30, 2026MalfunctionOtto Bock Healthcare Products Gmbh9615892-2026-00014
- KENEVOJun 17, 2026InjuryOtto Bock Healthcare Products Gmbh9615892-2026-00012
- NAVIIJun 4, 2026InjuryOssur Iceland Ehf3003764610-2026-00002
- KENEVOJun 1, 2026InjuryOtto Bock Healthcare Products Gmbh9615892-2026-00011
- GENIUM X3May 18, 2026MalfunctionOtto Bock Healthcare Products Gmbh9615892-2026-00010
Event type breakdown
Recalls
17 recall events for this product code
- Otto Bock Healthcare GmbHTerminatedJul 24, 2015
Ottobock Pheon 3R62 Knee Joint
Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.
Z-2261-2015 · View FDA record ↗ - Ossur H / FTerminatedFeb 6, 2012
Total Knee Junior Model Number 1100
Some units of the Total Knee Junior produced between November 25th, 2008 and through April, 2009 contain balancing units that may fail under extreme use over a long period. The fault is noncritical and no incidents or injuries resulting from this situation have been reported to Ossur at this stage. Over long term use (estimated to be in the four to six year range) the prosthetic device may fail a
Z-0965-2012 · View FDA record ↗ - Ossur Engineering, IncTerminatedMar 25, 2011
Ossur Total Knee, Model Number: 2100
The recall was initiated based on a finding by Ossur that some units of the Total Knee 2100 produced from October 19th, 2010 until January 21st 2011, contained back links that may compromise knee function prematurely.
Z-1822-2011 · View FDA record ↗ - Bock,Otto,Orthopedic Ind,IncTerminatedDec 16, 2009
Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany.
Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. This can cause the axes to gradually move out of the joint and result in a risk of falling for the user.
Z-0537-2010 · View FDA record ↗ - OssurTerminatedJul 12, 2007
Ossur Total Knee Model Number 2100, external knee prosthesis.
Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.
Z-1076-2007 · View FDA record ↗ - Medi Manufacturing IncTerminatedApr 24, 2007
Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).
Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.
Z-0759-2007 · View FDA record ↗ - Ossur North America IncTerminatedJul 4, 2006
Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.
The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Z-1197-06 · View FDA record ↗ - Ossur North America IncTerminatedJul 4, 2006
Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee.
The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Z-1198-06 · View FDA record ↗ - Ossur North America IncTerminatedJul 4, 2006
Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.
The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Z-1199-06 · View FDA record ↗ - Ossur North America IncTerminatedJul 4, 2006
Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.
The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Z-1200-06 · View FDA record ↗
Registered firms
65 firms currently registered for this product code
Orthotech Rehabilitation Co., Ltd.
Xiamen Fujian, CN
Cypress Adaptive, Llc
Atlantic Highlands, NJ, US
Pro Limb International Corp.
NEW TAIPEI CITY, TW
Ossur Iceland Ehf.
REYKJAVIK, IS
O And P De Mexico S.a. De C.v.
Guadalajara Jalisco, MX
Bionicm
Hongo Bunkyo-ku Tokyo, JP
Blatchford Products Limited
BASINGSTOKE Hampshire, GB
Brownmed
Spirit Lake, IA, US
Atulo Products
Newton, MA, US
Fillauer, Llc
CHATTANOOGA, TN, US
Baoji Shengtaike Industry & Trade Co. Ltd.
Baoji City Shanxi, CN
Ottobock Se & Co. Kgaa Formerly Known As Otto Bock Healthcare Gmbh
DUDERSTADT Lower Saxony, DE
Limber Prosthetics, Inc.
San Diego, CA, US
Imasen Engineering Corporation
Kakamigahara Gifu, JP
Cascade Orthopedic Supply, Lp.
Chico, CA, US
Ossur Europe B.v.
Eindhoven Noord-Brabant, NL
Zhejiang Qiangnao Technology Co.,ltd
hangzhou Zhejiang, CN
Nabtesco Corporation
KOBE Hyogo, JP
Willowwood Global Llc
Mt Sterling, OH, US
Brainportfolio Inc.
Austin, TX, US
Timed Inc.
Torrance, CA, US
Orliman Slu
La Pobla de Vallbona Valencia, ES
Trulife, Inc.
Bellingham, WA, US
College Park Industries
Warren, MI, US
St&g Usa Corporation / Choi
Brea, CA, US
510(k) clearances
1 clearances for this product code