FDA Device recall Z-1288-2015
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber an…
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber an… by Ossur H F, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1288-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-04 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ossur H F |
| Distribution | US |
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.
Identifiers
| code_info | LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1288-2015%22
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