FDAFDA · Food and drugs·Recall number Z-1820-2013
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Published August 7, 2013 · Recall initiated: July 11, 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
The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.
- Lot
- CATALOG NO. : Part Number: 1987-19-055 and lot numbers:130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1. In certain documentation, these alphanumeric lot numbers may appear with three zeros at the end (e.g. A1TAR1 may appear as A1TAR1000).
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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