S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Reported: July 11, 2012 Initiated: March 7, 2012 #Z-1934-2012
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.
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.
Details
- Recalling Firm
- Aesculap Implant Systems LLC
- Units Affected
- 15
- Distribution
- Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.. Recalled by Aesculap Implant Systems LLC. Units affected: 15.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 11, 2012. Severity: Moderate. Recall number: Z-1934-2012.
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