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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description 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
Recall Number Z-2114-2012
Classification Class II
Code Info 4 degree - SJ768T-US and 9 degree SJ780T-US
Product Distributed Qty 5
Reason For Recall 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.

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.
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