Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is
FDA device recall Z-2333-2012 · posted 2012-09-07 · Terminated
Recall details
- Recalling firm
- Aesculap Implant Systems LLC
- Reason for recall
- 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.
- Action taken
- Aesculap sent an "IMPORTANT PRODUCT REMOVAL NOTIFICATION" letter dated July 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Distribution Inventory Sheet was attached for customers to complete and return with the affected product. Contact the firm at (610) 984-9275 for questions regarding this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 5
- Distribution
- Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.
- Date initiated
- 2012-07-25
- Date posted
- 2012-09-07
- Date terminated
- 2014-03-18
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM (K100623) | Aesculap Implant Systems | 2010-06-09 |