Home › Device types › ISH
Component, External, Limb, Ankle/Foot
FDA product code ISH · Class 1 · Physical Medicine
24,105
Registered devices
93
Adverse events
13
Recalls
4
510(k) clearances
Devices with this code
Soleus — COLLEGE PARK INDUSTRIES, INC.Onyx — COLLEGE PARK INDUSTRIES, INC.Venture — COLLEGE PARK INDUSTRIES, INC.Venture — COLLEGE PARK INDUSTRIES, INC.Soleus — COLLEGE PARK INDUSTRIES, INC.Orbit — COLLEGE PARK INDUSTRIES, INC.Venture — COLLEGE PARK INDUSTRIES, INC.Venture — COLLEGE PARK INDUSTRIES, INC.TruStep — COLLEGE PARK INDUSTRIES, INC.TruStep — COLLEGE PARK INDUSTRIES, INC.Soleus — COLLEGE PARK INDUSTRIES, INC.Tempo — COLLEGE PARK INDUSTRIES, INC.Venture — COLLEGE PARK INDUSTRIES, INC.Venture — COLLEGE PARK INDUSTRIES, INC.TruStep — COLLEGE PARK INDUSTRIES, INC.Soleus — COLLEGE PARK INDUSTRIES, INC.Onyx — COLLEGE PARK INDUSTRIES, INC.Onyx — COLLEGE PARK INDUSTRIES, INC.Orbit — COLLEGE PARK INDUSTRIES, INC.Soleus — COLLEGE PARK INDUSTRIES, INC.Soleus — COLLEGE PARK INDUSTRIES, INC.Soleus — COLLEGE PARK INDUSTRIES, INC.TruStep — COLLEGE PARK INDUSTRIES, INC.Venture — COLLEGE PARK INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-12 | Ossur H / F | A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, |
| 2022-05-30 | Ossur Americas | Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is ap |
| 2015-10-23 | Otto Bock Healthcare GmbH | A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Funct |
| 2015-03-04 | Ossur H / F | The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly. Use of the product may cause the patient to fall w |
| 2013-10-24 | Ossur North America Inc | Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and |
| 2012-04-05 | College Park Industries, Inc. | An incorrect shorter part ( pyramid) was installed in the foot. A foot of this size and configuration requires a longer pyramid. Customers requiring the extra |
| 2012-02-12 | Ossur Americas, Inc. | OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. |
| 2007-06-20 | Applied Composite Technology | Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure. |
| 2006-11-03 | Ossur | Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising fun |
| 2006-10-03 | Southern Prosthetic Supply Co. | Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail |
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