LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femu

FDA device recall Z-1820-2013 · posted 2013-07-31 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

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.

Action taken

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)

Root cause

Device Design

Status

Terminated

Product code

JWH

Quantity affected

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,

Date initiated

2013-07-11

Date posted

2013-07-31

Date terminated

2014-07-10

Location

Warsaw, IN

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