Z-0831-2013 Class I Terminated
FDA device recall Z-0831-2013 was initiated by DePuy Orthopaedics, Inc. on Jan 4, 2013 and is designated Class I. Reason for recall: 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… The recall status is terminated (terminated May 20, 2014). Affected quantity: 162 total units (US) and 102 units total (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2013
- Initiation Date
- Jan 4, 2013
- Termination Date
- May 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162 total units (US) and 102 units total (OUS)
Product 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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Part number: 198720028 and Lot numbers: 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, and EN4KN1000.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0831-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026