Reported Aug 12, 2015 · Terminated

Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device,…

Titan Spine, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: TITAN SPINE, LLC · 6140 W Executive Dr · Mequon, WI · 53092-4499

Is this the product you have?

6 of 6 products · 6 lot codes

Recalled lot codes, grouped by product number
Part NumbersProduct Description
5302-3514
  • 03.5 x 14mm Locking Screws
5302-3516
  • 03.5 x 16mm Locking Screws
502-3518
  • 03.5 x 18mm Locking Screws
5302-3814
  • 03.8 x 14mm Locking Screws
5302-3816
  • 03.8 x 16 mm Locking Screws
5302-3818
  • 03.8 x 18mm Locking Screws
Lot codes and dates
  • Lot numbers
    • V03
    • V05
    • V06
Amount recalled
137 units

Where it was sold

Why it was recalled

Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 20, 2015 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.