Enforcement Report - Week of February 27, 2013
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-0830-2013 |
| Classification | Class I |
| Code Info | 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. |
| Product Distributed Qty | 162 total units (US) and 102 units total (OUS) |
| 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. |
Event Detail
| Event Id | 63783 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | DePuy Orthopaedics, Inc. |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-04 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
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