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

Recall Z-1456-2014 — Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.

U.S. FDA — Device Enforcement · United States · 2014-01-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1456-2014
Date of alert: 2014-01-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes, Inc.
Product category: device
Product type: Devices

Reported risk: The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

Recall Z-1456-2014 — Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.

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