Home › Device types › ISY
Joint, Knee, External Limb Component
FDA product code ISY · Class 1 · Physical Medicine
121
Registered devices
494
Adverse events
17
Recalls
1
510(k) clearances
Devices with this code
Power Knee — OSSUR AMERICAS, INC.Icon — COLLEGE PARK INDUSTRIES, INC.TEHLIN — TEH LIN PROSTHETIC & ORTHOPAEDIC INC.Icon — COLLEGE PARK INDUSTRIES, INC.Capital — COLLEGE PARK INDUSTRIES, INC.Rheo Knee — OSSUR AMERICAS, INC.Trulife — TRULIFE LIMITEDBIOSTEP XT — Alps South, LLCAura — COLLEGE PARK INDUSTRIES, INC.Capital — COLLEGE PARK INDUSTRIES, INC.Paseo Knee — CYPRESS ADAPTIVE, LLCTEHLIN — TEH LIN PROSTHETIC & ORTHOPAEDIC INC.Rheo Knee — OSSUR AMERICAS, INC.Rheo Knee — OSSUR AMERICAS, INC.Capital — COLLEGE PARK INDUSTRIES, INC.Trulife — TRULIFE LIMITEDIMAK Compression — BROWNMED, INC.Icon — COLLEGE PARK INDUSTRIES, INC.TEHLIN — TEH LIN PROSTHETIC & ORTHOPAEDIC INC.Capital — COLLEGE PARK INDUSTRIES, INC.Vista Ankle — CYPRESS ADAPTIVE, LLCRheo Knee — OSSUR AMERICAS, INC.Rheo Knee — OSSUR AMERICAS, INC.Rheo Knee — OSSUR AMERICAS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-10 | Ottobock Orthopedic Industrie | Some of the installed valve-inserts have a diameter smaller than the specification. |
| 2019-01-10 | Ottobock Orthopedic Industrie | Some of the installed valve-inserts have a diameter smaller than the specification. |
| 2019-01-10 | Ottobock Orthopedic Industrie | Some of the installed valve-inserts have a diameter smaller than the specification. |
| 2017-09-12 | Otto Bock Healthcare Product | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cau |
| 2017-09-12 | Otto Bock Healthcare Product | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cau |
| 2016-01-04 | Otto Bock Healthcare GmbH | Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error w |
| 2015-07-16 | Otto Bock Healthcare GmbH | Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking functio |
| 2011-02-11 | Ossur Engineering, Inc | 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 |
| 2009-08-10 | Ossur H / F | 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 |
| 2008-10-28 | Bock,Otto,Orthopedic Ind,Inc | 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 t |
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