FDA-Device2012-07-11Class II
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Aesculap Implant Systems LLC
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.
Sold states
Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
Affected count
15
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1934-2012Don't want to check this manually?
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