Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Recalled by Aesculap Implant Systems LLC Due to Aesculap Implant Systems, LLC has initiated a voluntary...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap Implant Systems LLC directly.
Affected 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.
Quantity: 15
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aesculap Implant Systems LLC
Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report