S4 Cervical recall
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during…
Why was S4 Cervical 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All distributed lot numbers and serial numbers
- Product
- S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during…
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 15
- Distribution
- Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
- Recall date
- July 11, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)