Synthes Multi-Vector Distractor Recalled Due to Shear Pin Specification Issues
Synthes USA is recalling 24 Multi-Vector Distractors because the sheer pin may not meet product specifications. The devices are used for mandibular bone lengthening.
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. The source text describes a manufacturing deviation regarding the sheer pin specifications but does not report any injuries, illnesses, or specific functional failures, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling 24 units of the Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. These medical devices are indicated for mandibular bone lengthening.
The recall was initiated because it was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. The affected units are identified by Part Number 487.966 and Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.
The recalled 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 HQ, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 24
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 (7)
- Part number 487.966 - Lot numbers 7823465
- 3817114
- 7806086
- 3824427
- 3808871
- 3794465
- and 7793336.
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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