Recall Z-0535-2013
Titan Spine, LLC · initiated October 19, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma.
Codes / lots: Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.
Reason for recall
Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
FDA-determined cause: Labeling False and Misleading
Action taken
Titan sent an Urgent Medical Device Recall letter dated October 19, 2012, to all affected customers. The letter described the problem , the product affected and the corrective measures to be taken. Customers were instructed to review any surgeries that were performed at the L5-51 level with the affected device. Customers were asked to communicate any complications associated with those cases to Titan Spine. Customers with questions should call 1-262-242-7801. For questions regarding this recall call 262-242-7801.
Details
- Recall number
- Z-0535-2013
- Initiated
- October 19, 2012
- Posted by FDA
- December 17, 2012
- Terminated
- January 14, 2013
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Quantity
- 92 pcs.
- Distribution
- Nationwide Distribution including NV
- Recalling firm
- Titan Spine, LLC, Mequon, WI