Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 12, 2014
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle durin
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
Ossur Americas, Inc. recalled The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulati… - a moderate-severity action.
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulati… was recalled by Ossur Americas, Inc. in February 12, 2014. Reason: OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of el…. Check the official notice for the remedy. Verify recall #Z-0936-2014 with the FDA Devices before acting.
The recall
Ossur Americas, Inc. issued this moderate-severity FDA Devices recall-OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of el….
- Moderate
- severity level
- 17 units
- affected scope
- Class II
- classification
- February 12, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0936-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0936-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on February 12, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Ossur Americas, Inc. is listed as the recalling firm, operating out of Foothill Ranch, CA. Federal records list the affected scope as 17 units.
The documented reason for this recall is: OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. Distribution data in the federal record shows the product reached: US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
17 units
Related Recalls
6
3 from same agency
Product description
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.
Reason for recall
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0936-2014 |
| Date reported | February 12, 2014 |
| Date initiated | February 12, 2012 |
| Recalling firm | Ossur Americas, Inc. |
| Firm location | Foothill Ranch, CA |
| Affected scope | 17 units |
| Distribution | US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0936-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.. Recalled by Ossur Americas, Inc.. Units affected: 17 units.
Why was this product recalled? ▼
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2014. Severity: Moderate. Recall number: Z-0936-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0936-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 12, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.