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.
What this means for you
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.
Related recalls
Same manufacturer · Synthes, Inc.
See all →- ModerateSynthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling
FDA (Devices) · 2020-08-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes 2.4mm Sterile Locking Screw Recall Due to Packaging Defect
FDA (Devices) · 2020-02-05
Same hazard · mis labeling
See all →- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- ModerateHenry Schein Recalls Dental Composite Capsules Due to Incorrect Packaging
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02