Recall Z-2368-2012— Lucero Medical LLC
Class II · Terminated
Class II FDA medical device recall by Lucero Medical LLC, initiated 2012-07-15, terminated 2013-02-20. It names one FDA 510(k) clearance: K093207. Product: 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.. Reason: The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation..
- Recalling firm
- Lucero Medical LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-15
- Terminated
- 2013-02-20
- Firm location
- Independence, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.