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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 component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 Variety of hip and knee implants and instruments, multiple uses.
Recall Number Z-1378-2013
Classification Class II
Code Info Catalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260
Product Distributed Qty 136 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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