BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used
FDA device recall Z-1664-2013 · posted 2013-07-05 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
- Action taken
- Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a modification has been implemented for the improved durability of S-LIFT Case Brackets and that SpineFrontier has initiated removal of these cases from the field. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FSM
- Quantity affected
- 12
- Distribution
- USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
- Date initiated
- 2013-05-17
- Date posted
- 2013-07-05
- Date terminated
- 2016-05-17
- 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 |