Synthes ProDisc-C 2 — Class II medical device recall Z-1669-2014
Terminated recall by Synthes, Inc., reported 2014-06-04, distributed nationwide. Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
| Recall number | Z-1669-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-04-29 |
| Classified | 2014-05-29 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2016-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 6,690 |
| Reason classes | device malfunction |
| Lot numbers | 5742506, 5742507, 5755970, 5755971, 5755972, 5755973, 5755974, 5755978, 5755979, 5755980, 5755981, 5755982, 5755983, 5755984, 5755985, 5755986, 5755987, 5755988, 5755989, 5755990, 5828298, 5828299, 5828300, 5828302, 6066520, 6113633, 6113671, 6159883, 6180175, 6320586, 6336108, 6336110, 6336111, 6336115, 6338068, 6338098, 6338099, 6338100, 6338101, 6338102 and 108 more |
| Model numbers | 03.820.161S, 03.820.1638, 03.820.167S, 03.820.169S |
Product
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.
Reason for recall
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
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-1669-2014. 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.