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

FDA device recall Z-1288-2015 · posted 2015-03-17 · Terminated

Recall details

Recalling firm

Ossur H / F

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

ISH

Quantity affected

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,

Date initiated

2015-03-04

Date posted

2015-03-17

Date terminated

2015-10-28

Location

Reykjavik, Iceland