Z-1288-2015Class II

LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module...

Name: Z-1288-2015 LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module...
Creator: Ossur H / F
Published: 2015-03-04
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2015-03-04 / Terminated / root cause: manufacturing process

FDA source

Ossur H / F began a recall of LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with... on 2015-03-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1288-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-04
Posted: 2015-03-17
Terminated: 2015-10-28
Recalling firm: Ossur Iceland ehf.
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
Product code: ISH Component, External, Limb, Ankle/Foot
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm's recall letter states the following instructions: Immediately examine inventory and quarantine product subject to the recall. In addition the firm asks if further distributed to identify the customers and notify them of the recall. The firm states that notification may be enhanced by providing a copy of the letter. The firm states that the recall notice needs to be passed along to all those who need to be aware. The firm also states that if customers are wearing a faulty product that they recommend them scheduling a visit to have the product replaced with a new LP Rotate that is currently available. The firm states that they can also arrange pick-up of defected products. For any questions the firm provides a customer service contact: Jamie Dutter, Senior Customer Service Representative.
Quantity in commerce: 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,
Product codes and lots: LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1288-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1288-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-17

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)