S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which ha
FDA device recall Z-0274-2014 · posted 2013-11-14 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
- Action taken
- SpineFrontier sent an Urgent Voluntary Recall letter dated August 28, 2013, to all affected customers. The letter identified teh product, the problem, and the action to be taken by the customer. Customers were asked to initiate the immediate return of the parts noted and complete an acknowledgement form and return it to SpineFrontier via fax or email. Customers with questions were instructed to call 978-232-3990. For questions regarding this recall call 978-232-3990.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 67
- Distribution
- Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
- Date initiated
- 2013-08-28
- Date posted
- 2013-11-14
- Date terminated
- 2018-09-13
- 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 |