Synthes CMF Battery Powered Driver Recalled for Misleading Case Graphics
Synthes is recalling CMF Battery Powered Drivers because the packaging graphics suggest off-label use with taps, which is not intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling/packaging issue (misleading graphics) that suggests off-label use, but no injuries or illnesses are reported in the source text.
Plain-English summary
Synthes, Inc. is recalling the CMF Battery Powered Driver, Part no. 305.840. This medical device is used to place screws in cranialfacial bones and to drill or tap holes to prepare bones for screw insertion. The recall involves 20,081 units distributed nationwide.
The recall was initiated because the graphic case containing the device includes outlines of taps and screwdriver blades. 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. The presence of these outlines suggests a potential off-label use that is not intended.
Healthcare providers and facilities that have received these devices should stop using them and contact Synthes, Inc. for instructions on return or replacement. The recall number is Z-1456-2014.
The recalled product
- Product
- 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.
- Manufacturer
- Synthes, Inc.
- Affected units
- 20,081
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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