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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 Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long
Recall Number Z-1386-2013
Classification Class II
Code Info Part No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32
Product Distributed Qty 26 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.