FDAFDA · Food and drugs·Recall number Z-0830-2013
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.
Published February 27, 2013 · Recall initiated: January 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- 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.
- Lot
- Part number: 198720024 and Lot numbers: 113812, 123509, 140578, 156210, 171659, 171660, 171661, 171662, 171663, 123509A, B34GE1000, B34GEA000, B4EGR1000, B4EGRA000, B4EGRB000, B4XFL1000, B4XFLA000, B5SH11000, B5SH1A000, B5SH1B, C74J11000, D14KG1000, E4RF21000, EN8CY1000, EN8CYA000, FC1MB1, and FC1MBA.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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