Recall Z-0417-2013
SpineFrontier, Inc. · initiated August 22, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
Codes / lots: Lot Numbers: 012064-001
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
FDA-determined cause: Labeling design
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.
Details
- Recall number
- Z-0417-2013
- Initiated
- August 22, 2012
- Posted by FDA
- November 21, 2012
- Terminated
- June 11, 2015
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 19 units
- Distribution
- US Nationwide including the states of: MA and TX.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA