Symbionic Leg
KIT Symbionic 3 Unity C3S263Y
1manufacturer
118catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
Record
| Listed by | Ossur Americas, United States |
|---|---|
| FDA product code | ISW |
| Device type | Assembly, Knee/Shank/Ankle/Foot, External |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-16 |
| Record revised | 2021-03-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 0 to 90 % RH; Storage environment humidity 0 to 90 % RH; Handling environment temperature -10 to 40 °C; Storage environment temperature -10 to 45 °C |
| Distribution end date | 2018-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMBU3263 | Withdrawn | |
| SMBE8273 | Withdrawn | |
| SMBE4273 | Withdrawn | |
| SMBU4303 | Withdrawn | |
| SMBE6263 | Withdrawn | |
| SMBE4263 | Withdrawn | |
| SMBE2273 | Withdrawn | |
| SMBU4253 | Withdrawn | |
| SMBU2283 | Withdrawn | |
| SMBU2273 | Withdrawn | |
| SMBU5273 | Withdrawn | |
| SMBE5243 | Withdrawn | |
| SMBU2233 | Withdrawn | |
| SMBE2233 | Withdrawn | |
| SBL12112 | Withdrawn | |
| SMBU4293 | Withdrawn | |
| SMBE6273 | Withdrawn | |
| SMBE7263 | Withdrawn | |
| SMBU8283 | Withdrawn | |
| SMBE8283 | Withdrawn | |
| SMBU4243 | Withdrawn | |
| SMBU5223 | Withdrawn | |
| SMBE6293 | Withdrawn | |
| SMBE2283 | Withdrawn | |
| SMBU3273 | Withdrawn | |
| SMBE7273 | Withdrawn | |
| SBL12102 | Withdrawn | |
| SMBE3243 | Withdrawn | |
| SMBU8293 | Withdrawn | |
| SMBU8253 | Withdrawn | |
| SMBE4233 | Withdrawn | |
| SMBU3233 | Withdrawn | |
| SMBU7283 | Withdrawn | |
| SMBE4303 | Withdrawn | |
| SMBU4233 | Withdrawn | |
| SMBU7253 | Withdrawn | |
| SMBE3233 | Withdrawn | |
| SMBE5263 | Withdrawn | |
| SMBU4273 | Withdrawn | |
| SMBE2223 | Withdrawn | |
| SMBU3283 | Withdrawn | |
| SMBE7253 | Withdrawn | |
| SMBU5233 | Withdrawn | |
| SMBE8263 | Withdrawn | |
| SMBE5273 | Withdrawn | |
| SMBE3303 | Withdrawn | |
| SMBE7303 | Withdrawn | |
| SMBE6283 | Withdrawn | |
| SMBU6303 | Withdrawn | |
| SMBU7263 | Withdrawn | |
| SMBE8293 | Withdrawn | |
| SMBE6253 | Withdrawn | |
| SMBU4283 | Withdrawn | |
| SMBU5243 | Withdrawn | |
| SMBU7293 | Withdrawn | |
| SMBU6283 | Withdrawn | |
| SMBU6253 | Withdrawn | |
| SMBU3293 | Withdrawn | |
| SMBU8303 | Withdrawn | |
| SMBE3293 | Withdrawn | |
| SMBE4223 | Withdrawn | |
| SMBE1243 | Withdrawn | |
| SMBU2263 | Withdrawn | |
| SMBU5253 | Withdrawn | |
| SMBE3273 | Withdrawn | |
| SMBU6273 | Withdrawn | |
| SMBE5253 | Withdrawn | |
| SMBE1233 | Withdrawn | |
| SMBE5233 | Withdrawn | |
| SMBU5293 | Withdrawn | |
| SMBE4293 | Withdrawn | |
| SMBU4223 | Withdrawn | |
| SMBU1253 | Withdrawn | |
| SMBU4263 | Withdrawn | |
| SMBE4283 | Withdrawn | |
| SMBU3303 | Withdrawn | |
| SMBU7303 | Withdrawn | |
| SMBU2253 | Withdrawn | |
| SMBE5303 | Withdrawn | |
| SMBU8263 | Withdrawn | |
| SBL13110 | Withdrawn | |
| SMBU3243 | Withdrawn | |
| SMBE4253 | Withdrawn | |
| SMBU6263 | Withdrawn | |
| SMBE1253 | Withdrawn | |
| SMBE8303 | Withdrawn | |
| SMBU3223 | Withdrawn | |
| SMBU8273 | Withdrawn | |
| SMBE5283 | Withdrawn | |
| SMBE2243 | Withdrawn | |
| SMBU5263 | Withdrawn | |
| SMBE3263 | Withdrawn | |
| SMBE7283 | Withdrawn | |
| SMBU3253 | Withdrawn | |
| SMBU2223 | Withdrawn | |
| SMBE5223 | Withdrawn | |
| SMBU1243 | Withdrawn | |
| SMBE2263 | Withdrawn | |
| SBL13210 | Withdrawn | |
| SMBE8253 | Withdrawn | |
| SMBU6293 | Withdrawn | |
| SMBE3253 | Withdrawn | |
| SBL13211 | Withdrawn | |
| SBL13111 | Withdrawn | |
| SMBE7293 | Withdrawn | |
| SMBU5283 | Withdrawn | |
| SMBU2243 | Withdrawn | |
| SMBE4243 | Withdrawn | |
| SMBE2253 | Withdrawn | |
| SMBU1223 | Withdrawn | |
| SMBU1233 | Withdrawn | |
| SMBE3283 | Withdrawn | |
| SMBU7273 | Withdrawn | |
| SMBE6303 | Withdrawn | |
| SMBE5293 | Withdrawn | |
| SMBE1223 | Withdrawn | |
| SMBU5303 | Withdrawn | |
| SMBE3223 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Empower | Otto Bock Healthcare GmbH | 621 |
| Walkasins | Rxfunction Inc. | 18 |
| Power Knee | Ossur Americas | 11 |
| BiOM T2 | Bionx Medical Technologies, Inc. | 9 |
| emPOWER | Bionx Medical Technologies, Inc. | 7 |
| Bio Leg™ | Bionicm | 4 |
| Rheo Knee | Ossur Americas | 3 |
| BiOM T2 | Otto Bock Healthcare GmbH | 2 |
| C-Matt | Casco Manufacturing Solutions, Inc. | 1 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-08-29 | Class II | Device Design | Battery may dislodge from the Power Knee | 190 devices |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.