LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 863
FDA device recall Z-0400-2014 · posted 2013-11-26 · Terminated
Recall details
- Recalling firm
- Lanx, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OVD
- Quantity affected
- 25 units
- Distribution
- Nationwide Distribution including AZ, PA, WI, NY, TX, PR, and TN.
- Date initiated
- 2013-11-04
- Date posted
- 2013-11-26
- Date terminated
- 2015-12-29
- Location
- Broomfield, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LANX FUSION SYSTEM (K131547) | Lanx, Inc. | 2013-07-12 |
| LANX FUSION SYSTEM- SA (K123767) | Lanx, Inc. | 2013-03-18 |