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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 UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses.
Recall Number Z-1380-2013
Classification Class II
Code Info Catalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050
Product Distributed Qty 57 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.