Synthes Recalls Multi Vector Distractor Pin Holding Clamps Due to Binding
Synthes USA is voluntarily removing Multi Vector Distractor Pin Holding Clamps because the clamp and nut construct may fail to engage threads and bind.
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 removal for a mechanical defect where the source explicitly states it is not likely that a serious adverse event will result, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes USA HQ, Inc. is initiating a voluntary removal of 121 units of the Multi Vector Distractor Pin Holding Clamp, limited bone stock. The affected devices are part of the Multi Vector Distractor system used for mandibular bone lengthening procedures, including for congenital mandibular deficiencies or post-traumatic defects.
The recall was initiated after the firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. The source text notes that it is not likely that a serious adverse event will result due to a nonconforming clamp.
The affected products are distributed nationwide in the United States, including in Massachusetts, Texas, Minnesota, South Carolina, Utah, Virginia, and New York. Specific part numbers and lot numbers are listed in the structured product information. Healthcare providers and patients should contact Synthes USA HQ, Inc. for instructions on how to proceed with the removal.
The recalled product
- Product
- Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 121
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 (14)
- Titanium Multi Vector Distractor Pin Holding Clamp
- body
- limited bone stock Part # 487.941 with lot numbers: 3769720
- 3779569
- 3788731
- 3794434
- 7806093
- 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp
- ramus
- limited bone stock Part # 487.942 with lot numbers: 3769706
- 3779571
- 3788741
- 7806096
- 7823464.
Distribution
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