Synthes Dens Instrument Set Recalled Due to Lack of Indicated Screws
Synthes USA HQ, Inc. is recalling 148 Dens Instrument Sets because there are no screws specifically indicated for the procedure.
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 2/5 (Moderate).
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 a voluntary precautionary action to remove a product due to a lack of specifically indicated components, with no reported injuries or illnesses.
Plain-English summary
Synthes USA HQ, Inc. is recalling 148 units of the Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030, also known as the Anterior Column Retractor Set. The recall covers all lots of this product.
The instrument set is designed to facilitate the anterior internal fixation of the Dens (odontoid process) for the reduction of Type II and shallow Type III fractures. The recall is being conducted because there are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation, leading to the removal of the affected product.
The product was distributed nationwide, including in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont, Wisconsin, West Virginia, and Wyoming. Users should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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 has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 148
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)
- Part number 687.030
- All Lots
Distribution
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