Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 preparati — recall Z-1669-2014

U.S. FDA — Device Enforcement · United States · 2014-04-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1669-2014
Date of alert: 2014-04-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes, Inc.
Product category: device
Product type: Devices

Reported risk: Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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