LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Enforcement
- Recall Number
- Z-0831-2013
- Event ID
- 63783
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- DePuy Orthopaedics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 27, 2013
- Initiation Date
- January 4, 2013
- Classification Date
- February 15, 2013
- Termination Date
- May 20, 2014
- Address
- 700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States
Description
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Part number: 198720028 and Lot numbers: 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, and EN4KN1000.
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.
162 total units (US) and 102 units total (OUS)