LANX Timberline MPF Lateral Modular Plate Fixation System Straight… — Class II medical device recall Z-0400-2014
Terminated recall by Lanx, Inc., reported 2013-12-04, distributed nationwide. Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because th
| Recall number | Z-0400-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lanx, Inc., Broomfield, CO, United States |
| Recall initiated | 2013-11-04 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-12-29 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| Lot numbers | TU00090, TU00157, TU00242 |
| Model numbers | 8630-0107 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0400-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.