Recall Z-1288-2015— Ossur H / F
Class II · Terminated
Class II FDA medical device recall by Ossur H / F, initiated 2015-03-04, terminated 2015-10-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Ossur H / F
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-04
- Terminated
- 2015-10-28
- Firm location
- Reykjavik, Iceland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.