Synthes Dens Instrument Set recall
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set…
Why was Synthes Dens Instrument Set recalled?
The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number 687.030, All Lots
- Product
- Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 148
- Distribution
- Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY.
- Recall date
- April 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)