LP Rotate Foot System prosthetic device for fitting lower extremity… — Class II medical device recall Z-1288-2015
Terminated recall by Ossur H / F, reported 2015-03-25, distributed nationwide. The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly.
| Recall number | Z-1288-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur H / F, Reykjavik, Iceland |
| Recall initiated | 2015-03-04 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-10-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BG, CA, CZ, DE, ES, FI, FR, GB, IL, JP, KR, MX, PL, SE |
| Lot numbers | HF141022 |
| Model numbers | 1-6 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1288-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.