Joint, Knee, External Limb Component
FDA adverse event reports and recall history for joint, knee, external limb component (product code ISY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 490
- Deaths
- 3
- Injuries
- 250
- Malfunctions
- 225
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-07-24TerminatedComponent design/selection
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
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.
- 2012-02-06TerminatedNonconforming Material/Component
Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system.
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
- 2011-03-25TerminatedProcess design
Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads.
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.
- 2009-12-16TerminatedEmployee error
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.
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.
- 2007-07-12TerminatedOther
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.
- 2007-04-24TerminatedOther
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.
- 2006-07-04TerminatedOther
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.
- 2006-07-04TerminatedOther
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.
- 2006-07-04TerminatedOther
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.
- 2006-07-04TerminatedOther
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.
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