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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Recall Number Z-1820-2013
Classification Class I
Code Info 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).
Product Distributed Qty 57 U.S. / 37 OUS
Reason For Recall The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.

Event Detail

Event Id 65591
Product Type Devices
Status Ongoing
Recalling Firm DePuy Orthopaedics, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-11
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.