Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 1, 2015
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ossur H / F recalled The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity… - a moderate-severity action.
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity… was recalled by Ossur H / F in April 1, 2015. Reason: The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the …. Check the official notice for the remedy. Verify recall #Z-1322-2015 with the FDA Devices before acting.
The recall
Ossur H / F issued this moderate-severity FDA Devices recall-The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the ….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- April 1, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1322-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1322-2015) was formally reported on April 1, 2015, with the manufacturer initiating the action on February 26, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Ossur H / F is listed as the recalling firm, operating out of Reykjavik. Federal records list the affected scope as 4715 units (2 units affected).
The documented reason for this recall is: The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process. Distribution data in the federal record shows the product reached: Worldwide distribution: US distribution in TN and country of: Austria.. 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
4715 units (2 units affected)
Related Recalls
6
3 from same agency
Product description
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
Reason for recall
The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1322-2015 |
| Date reported | April 1, 2015 |
| Date initiated | February 26, 2015 |
| Recalling firm | Ossur H / F |
| Firm location | Reykjavik |
| Affected scope | 4715 units (2 units affected) |
| Distribution | Worldwide distribution: US distribution in TN and country of: Austria. |
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-1322-2015) 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 Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.. Recalled by Ossur H / F. Units affected: 4715 units (2 units affected).
Why was this product recalled? ▼
The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2015. Severity: Moderate. Recall number: Z-1322-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US distribution in TN and country of: Austria..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1322-2015) 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 April 1, 2015. 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.