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Trulife
TRULIFE LIMITED · Model SEF190-24-L-1S4 · UDI-DI 00645517818191
4
510(k) clearances
93
Adverse events
13
Recalls
87
Facilities
Description
TRULIFE ENERGY FOOT SIZE 24 LEFT #1
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, leading to the poten |
| 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 applied to the foot. |
| 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 Function to move the foot |
| 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 with continued use, a |
| 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 ultimately separate |
| 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 firm configuration |
| 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 function and stability |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.