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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62626
Product Type Devices
Status Ongoing
Recalling Firm Aesculap Implant Systems LLC
City Center Valley
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-12
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Nationwide Distribution - including the states of CO, OH, OK and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient 4 degree - SJ768T-US and 9 degree SJ780T-US Class II The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree trial instrument (SJ768T-US). The incorrect etching was not identified at final inspection. 5 Z-2114-2012
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