The Recall Desk
ModerateFDA (Devices)·Z-0400-2014·Announced 2013-12-04

Lanx Recalls Timberline MPF Straight Split Tip Driver Due to Sizing Defect

Lanx, Inc. is recalling 25 units of the Timberline MPF Straight Split Tip Driver - Short because the tip is oversized.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity score.

Plain-English summary

Lanx, Inc. is recalling 25 units of the Timberline MPF Straight Split Tip Driver - Short (Model Number 8630-0107). The recall affects specific lots (TU00090, TU00157, and TU00242) that were distributed nationwide, including in Arizona, Pennsylvania, Wisconsin, New York, Texas, Puerto Rico, and Tennessee.

The recall was initiated because the width of the most distal end of the driver (the tip of the hex portion) is oversized. The driver is a component of the Timberline MPF Lateral Modular Plate Fixation System, which is an intervertebral body fusion device used to drive titanium screws through a plate and into the vertebrae.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and facilities should stop using the affected drivers and contact Lanx, Inc. for instructions on return or replacement.

The recalled product

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 sp
Manufacturer
Lanx, Inc.
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot No: TU00090
  • TU00157 and TU00242

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Related recalls

Same hazard · manufacturing defect

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