S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surg
FDA device recall Z-0417-2013 · posted 2012-11-21 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
- Action taken
- Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 19 units
- Distribution
- US Nationwide including the states of: MA and TX.
- Date initiated
- 2012-08-22
- Date posted
- 2012-11-21
- Date terminated
- 2015-06-11
- 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 |