SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fus
FDA device recall Z-1565-2014 · posted 2014-05-07 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
- Action taken
- Spine Frontier sent an Urgent Notification dated December 23, 2011, consignees. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached acknowledgement form. For questions call 866-914-7717
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 30 devices
- Distribution
- US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
- Date initiated
- 2011-12-23
- Date posted
- 2014-05-07
- Date terminated
- 2014-05-20
- 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 |