LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.
Recall
- Recall Number
- Z-0400-2014
- Event Number
- 66836
- Firm
- Lanx, Inc.
- FEI Number
- 3012447612
- Product Code
- OVD
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 4, 2013
- Posted
- November 26, 2013
- Terminated
- December 29, 2015
- Address
- 310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464
Description
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.
Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized.
LANX sent an URGENT: Recall letter dated November 5, 2013, to all affected customers via Federal Express, Overnight delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product to the firm. Customers with questions were instructed to contact Field Inventory Management. For questions regarding this recall call 303-501-8402.
Nationwide Distribution including AZ, PA, WI, NY, TX, PR, and TN.
25 units