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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Recall Number Z-1934-2012
Classification Class II
Code Info All distributed lot numbers and serial numbers
Product Distributed Qty 15
Reason For Recall 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.

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 Letter
Distribution Pattern Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .