Synthes Multi-Vector Distractor Body Recalled for Manufacturing Defect
Synthes USA HQ, Inc. is recalling two units of the Multi-Vector Distractor Body because the sheer pin may not meet product specifications.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling two units of the Synthes Multi-Vector Distractor Body, Part Number 487.931, used for mandibular bone lengthening. The recall was initiated after it was discovered that the sheer pin on the device may not be made according to product specifications.
The affected units were distributed nationwide, including in Colorado, Louisiana, Maryland, Minnesota, New York, Pennsylvania, Rhode Island, Tennessee, Texas, and Utah. The specific part number is 487.831, and the affected lot numbers are 7826459, 7750064, 7667285, and 7806090.
Healthcare providers and patients should contact Synthes USA HQ, Inc. for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 2
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 (4)
- Part number 487.831 - Lot numbers 7826459
- 7750064
- 7667285
- and 7806090.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Synthes USA HQ, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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