Synthes Dens Instrument Set — Class II medical device recall Z-1016-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-04-03, distributed nationwide. The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid p
| Recall number | Z-1016-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-01-11 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2015-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 148 |
| Reason classes | device malfunction |
| Model numbers | 687.030 |
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 fractures, as proposed by Anderson and d'Alonzo.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1016-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.