Synthes Multi-Vector Distractor Recalled for Non-Conforming Shear Pin
Synthes USA is recalling 18 Multi-Vector Distractors because the shear pin may not meet product specifications.
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 classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing deviation (shear pin specifications) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling 18 units of the Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. This medical device is used for mandibular bone lengthening.
The recall was initiated because it was discovered that the shear pin on the device may not be made according to product specifications. The affected units are associated with lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, and 3794466.
The devices were distributed nationwide, including in Colorado, Louisiana, Maryland, Minnesota, New York, Pennsylvania, Rhode Island, Tennessee, Texas, and Utah. Healthcare providers and patients should contact Synthes USA for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 18
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 (6)
- Part number 487.967 - Lot numbers 7883454
- 3808876
- 7824423
- 3800758
- 3817116
- 3794466
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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