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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
Recall Number Z-1383-2013
Classification Class II
Code Info Item No. 1503-3042 1503-3144 1503-3146 1503-3148 1503-3150 1503-3152 1503-3154 1503-3156
Product Distributed Qty 37 units
Reason For Recall The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Event Detail

Event Id 64588
Product Type Devices
Status Ongoing
Recalling Firm Orthopedic Alliance LLC
City Murrieta
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the states of CA, MD, TX, NV, and WI.