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U.S. Department of Health and Human Services

Class 1 Device Recall Dovetail Intercalary component

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 Class 1 Recall
Dovetail Intercalary component
see related information
Date Posted July 31, 2013
Recall Status1 Terminated on July 10, 2014
Recall Number Z-1820-2013
Recall Event ID 65591
Premarket Notification
510(K) Number
K041085 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Code Information 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).
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw, Indiana 46582-3994
For Additional Information Contact Mindy Tinsley
574-372-7136
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action On 7/11/13, URGENT MEDICAL DEVICE RECALL NOTIFICATIONS were sent to consignees: Depuy Distributors, hospitals, and surgeons. End-user Hospital Customers will submit reconciliation forms to DePuy. Possible clinical implications of device failure are stated in these notifications, including poor mechanics and loss of function, pain, component dislocation, adverse tissue reaction, bone damage, potential need for revision surgery and the risks associated with this type of surgery. A patient letter will be included with the surgeon letter to assist in surgeon's notification and discussion with patients. The devices will be returned to DePuy Warsaw through the normal DePuy Returns process, to attention of Returns and marking H13-13 on the outside of the box. If a patient presents with a fractured LPS" Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines LPS" Lower Extremity Dovetail Intercalary component is the best treatment option, DePuy plans to make the LPS" Lower Extremity Dovetail Intercalary component available through authorized approvals. Directions on how to purchase the component are provided in the Recall Communications. Any questions or concerns about the recall, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8am-5pm EDT).
Quantity in Commerce 58 U.S. / 39 OUS
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = DEPUY, INC.
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