Aesculap S4 Cervical Revision Instruments Recalled for Tolerance Issues
Aesculap Implant Systems LLC is voluntarily removing S4 Cervical Revision Instruments because they may not thread into screws properly during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could compromise surgical outcomes, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aesculap Implant Systems LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument, which is part of the S4C Occipital Instrument Set. The specific models involved are the FW099R and FW101R. These instruments are designed to assist in the removal of an occipital cervical screw during revision surgery.
The recall was initiated because the instruments may not thread into the screw properly during a revision surgery. This issue is attributed to tolerance issues between the two instruments. The recall covers 15 units that were distributed nationwide, including the states of California, Colorado, Illinois, Louisiana, Nevada, Ohio, and Texas.
Healthcare providers and facilities that have received these instruments should stop using them immediately. Aesculap Implant Systems LLC is the recalling firm responsible for the removal of these devices from the market.
The recalled product
- 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
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All distributed lot numbers and serial numbers
Distribution
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