Reported Mar 25, 2015 · Terminated
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with…
Ossur H / F
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ossur H / F · Grjothals 5 · Reykjavik · N/A
Is this the product you have?
- 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 heightwith 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 weight147kg (325lbs) -Available in sizes 22-30
- Lot codes and dates
- LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022
- Amount recalled
- 2,194 (1,464 in U.S. and 730 internationally)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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