Aesculap S4 Element 4.5mm Polyaxial Screws recall
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for…
Why was Aesculap S4 Element 4.5mm Polyaxial Screws recalled?
There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
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 lots and serial numbers
- Product
- Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for…
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 5
- Distribution
- Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.
- Recall date
- September 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)