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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 Femoral head, standard, Æ26mm, +0mm Femoral head,medium, Æ26mm,+3mm Femoral head, long, Æ26mm, +6mm Femoral head, X-long, Æ26mm, +9mm Femoral head, Æ28mm, -3mm Femoral head, Æ28mm, +0mm Femoral head, Æ28mm, +5mm Femoral head, Æ28mm, +10mm Femoral head, Æ32mm, -3mm Femoral head, Æ32mm, +0mm Femoral head, Æ32mm, +5mm Femoral head, Æ32mm, +10mm Femoral head, Æ36mm, -3mm Femoral head, Æ36mm, +0mm Femoral head, Æ36mm, +5mm Femoral head, Æ36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.
Recall Number Z-1382-2013
Classification Class II
Code Info Item No. 1201-1126 1201-1326 1201-1526 1201-1726 1201-1028 1201-1128 1201-1428 1201-1828 1201-1032 1201-1132 1201-1432 1201-1832 1201-1036 1201-1136 1201-1436 1201-1836
Product Distributed Qty 21 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.
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