BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
This recall has been terminated (originally issued July 5, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- May 17, 2013
- Posted
- July 5, 2013
- Terminated
- May 17, 2016
- Recall Number
- Z-1664-2013
- Quantity
- 12
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
Distribution
USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
Lot / Code Info
Lot/Serial Numbers: 7201.007 and 7201.007-1
Root Cause
Component design/selection
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.