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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67499

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 30, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1456-2014
Recall number
Z-1456-2014
Initiated
January 30, 2014
Classification
Class II
Status
Terminated
Recalling firm
Synthes, Inc.
Quantity
20081

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 6150803, 6167974, 6167975, 6218358, 6222322, 6258395, 6365430, 6365431, 6390225, 6425013, 6456634, 6487035, 6556704, 6624880, 6650136, 6668870, 6743859, 6844968, 6926708, 6983799, 7008819, 7038706, 7221395, 7138319.

Distribution pattern

Nationwide Distribution

Field note

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