Synthes CMF Distraction System Recalled for Misalignment
Synthes USA HQ, Inc. is voluntarily recalling 10 units of the Synthes CMF Distraction System due to a misalignment issue that prevents the attachment of specific foot plates.
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: The recall is a voluntary precautionary action for a mechanical defect (misalignment) that prevents the attachment of components. The source text does not report any injuries, illnesses, or deaths, and the defect is a functional failure rather than a direct safety hazard like a fracture or contamination.
Plain-English summary
Synthes USA HQ, Inc. has initiated a voluntary recall of the BC Distractor Body, which is a component of the Craniomaxillofacial (CMF) Distraction System. The recall involves 10 units of the product, which is intended for use as a bone stabilizer and lengthening device for the mandibular body and ramus.
The recall was initiated due to a misalignment issue where the slot in the barrel of the BC distractor was rotated. This defect makes it impossible to attach the B-type and C-type foot plates to the device. The affected units are identified by Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
The product was distributed nationwide, including in Pennsylvania, Connecticut, Delaware, and New York. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for handling the recalled units.
The recalled product
- Product
- Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It…
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 10
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 (1)
- Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
Distribution
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