Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Recall
- Recall Number
- Z-2368-2012
- Event Number
- 62926
- Firm
- Lucero Medical LLC
- FEI Number
- 3008775608
- Product Code
- MQP
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- July 15, 2012
- Posted
- September 11, 2012
- Terminated
- February 20, 2013
- Address
- 6100 Oak Tree Blvd, Ste 200, Independence, OH, 44131-6914
Description
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Lucero Medical sent a Field Correction Notice letter dated July 15, 2012 to it's sole consignee. The notice identified the affected product., problem and actions to be taken. The customer was instructed to complete the response card and submit back to their local Lucero Medical Representative.
US Nationwide Distribution
169