Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LP Rotate Foot System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall LP Rotate Foot System see related information
Date Initiated by Firm March 04, 2015
Date Posted March 17, 2015
Recall Status1 Terminated 3 on October 28, 2015
Recall Number Z-1288-2015
Recall Event ID 70648
Product Classification Component, external, limb, ankle/foot - Product Code ISH
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
Code Information LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022
Recalling Firm/
Manufacturer		 Ossur H / F
Grjothals 5
Reykjavik Iceland
For Additional Information Contact
949-382-3883
Manufacturer 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.
FDA Determined
Cause 2		 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-