Recall Z-1664-2013
SpineFrontier, Inc. · initiated May 17, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot/Serial Numbers: 7201.007 and 7201.007-1
Reason for recall
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
FDA-determined 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.
Details
- Recall number
- Z-1664-2013
- Initiated
- May 17, 2013
- Posted by FDA
- July 5, 2013
- Terminated
- May 17, 2016
- Product code
- FSM – Tray, Surgical, Instrument
- Quantity
- 12
- Distribution
- USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA