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Aesculap Implant Systems LLC recalls S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an oc
Recalled July 11, 2012 · FDA recall Z-1934-2012 · Aesculap Implant Systems
Hazard
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. · FDA Class II
Units
15
Sold at
Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
Description
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.
Product
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →