Z-2368-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2012
- Initiation Date
- July 15, 2012
- Termination Date
- February 20, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Part #-Lot # (s): 762.010L-110738; 762.013L-110738; 762.017L-60611, 90611, and 512171; 762.019L-60611, 90611, 100308, 1261901, and 20121901; 762.021L-60611, 90611, 100308, 110106, 20122101, and 20122102; 762.023L- 90611, 100209, 100218, 00706, 10709, 20122301, and 20122302; 762.025L-90611, 100218, 110106, 20122501, and 20122502; 762.027L-60611, 90611, 100706, and 20122071; 762.029L-90611, 1262901, and 90611; 762.031L-1263101; 762.033L-90611, 91002, and 1263301; 762.041L-90611 and 1264101; 762.043L-90611 and 1264301; 762.045L-90611; 762.047L-90611; 762.049L-90611; 762.051L-90611 and 512511; 762.053L-90611; 762.090L-90611; 762.090L-2.0-100206 and 100342; 762.090L-2.5-100206; 762.159L-110505; 762.237L-91002; 762.243L-91018; 762.270L-91018; 762.290L-91018; 762.731L-91018; 762.735L-91002; 762.767L-91018; and 762.790L-91018.