Recall Z-0400-2014 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Lanx, Inc.
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
| Date | Nov 26, 2013 (initiated Nov 4, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 25 units |
| Distribution | Nationwide Distribution including AZ, PA, WI, NY, TX, PR, and TN. |
| FDA record | Open on fda.gov |