T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have
FDA device recall Z-1932-2013 · posted 2013-08-08 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
- Action taken
- On August 29, 2011, The Supply Chain Team was notified of the recall via email. They were informed that all handles are being pulled from the field. This resulted in the return of all T-Handles to SpineFrontier. Further questions please call (978) 232-3990.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MDM
- Quantity affected
- 11
- Distribution
- US Distribution including the states of MA, NV and TX.
- Date initiated
- 2012-08-29
- Date posted
- 2013-08-08
- Date terminated
- 2013-10-18
- Location
- Beverly, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S-LIF INTERVERTEBRAL BODY FUSION DEVICE (K092815) | Spinefrontier, Inc. | 2010-06-30 |