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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID 62240
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 2012-03-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery. All distributed lot numbers and serial numbers Class II Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments. 15 Z-1934-2012