FDA Devices recall · Reported March 25, 2015
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2 ) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30
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, …
Ossur H / F recalled LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low … - a moderate-severity action.
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low … was recalled by Ossur H / F in March 25, 2015. Reason: The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly.…. Check the official notice for the remedy. Verify recall #Z-1288-2015 with the FDA Devices before acting.
The recall
Ossur H / F issued this moderate-severity FDA Devices recall-The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly.….
- Moderate
- severity level
- Class II
- classification
- March 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1288-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1288-2015) was formally reported on March 25, 2015, with the manufacturer initiating the action on March 4, 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 2,194 (1,464 in U.S. and 730 internationally).
The documented reason for this recall is: 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, as the shock module can become loose fro… Distribution data in the federal record shows the product reached: Nationwide within the U.S. and internationally to the following foreign countries; Belgium, United Kingdom, Germany, Czech Republic, France, Israel, Poland, Spain, Australia, Japan, Mexico, Bulgaria, Canada, South Korea…. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2 ) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30
Reason for recall
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, as the shock module can become loose from the foot blade.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1288-2015 |
| Date reported | March 25, 2015 |
| Date initiated | March 4, 2015 |
| Recalling firm | Ossur H / F |
| Firm location | Reykjavik |
| Affected scope | 2,194 (1,464 in U.S. and 730 internationally) |
| Distribution | Nationwide within the U.S. and internationally to the following foreign countries; Belgium, United Kingdom, Germany, Czech Republic, France, Israel, Poland, Spain, Australia, Japan, Mexico, Bulgaria, Canada, South Korea, Sweden, Finland, |
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-1288-2015) 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.
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