Cardinal Health Recalls V. Mueller Spinal Distraction Screws Due to Corrosion
Cardinal Health 200, LLC is recalling V. Mueller Neuro/Spine Shadow-Line Spinal Distraction Screws because corrosion was demonstrated on the screw surface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (corrosion) in a medical device used for spinal distraction, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Cardinal Health 200, LLC is recalling V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, in various sizes (12mm, 14mm, 16mm, and 18mm). The recall involves 72,076 units of the product.
The recall was initiated due to a potential risk associated with corrosion demonstrated on the distraction screw surface. The affected products were distributed worldwide, including the United States (nationwide), Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland, and Thailand.
The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the corrosion.
The recalled product
- Product
- V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 72,076
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 (20)
- J11 10/27/2011
- D12 04/24/2012
- F12 06/06/2012
- K12 11/06/2012
- L12 12/12/2012
- F13 06/20/2013
- H13 08/26/2013
- I13 09/04/2013
- J13 10/29/2013
- A14 01/03/2014
- A14 01/22/2014
- C14 03/06/2014
- D14 04/24/2014
- G14 07/31/2014
- I14 09/03/2014
- L14 12/16/2014
- D15 04/01/2015
- F15 06/04/2015
- H15 08/11 /2015
- I15 09/23/2015
Distribution
Distributed nationwide across the United States.
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