Synthes Titanium Midface Distractor Recalled Due to Fit Issues
Synthes USA is recalling 596 Titanium Midface Distractors because oversized tabs may prevent footplates from fitting properly.
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 describes a mechanical fit issue without reporting any injuries, hospitalizations, or deaths. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Synthes USA HQ, Inc. is recalling 596 units of the Synthes Titanium Midface Distractor, MR Conditional (Part number 487.982). The device is used for the temporary stabilization and gradual lengthening of cranial or midfacial bones.
The recall was initiated because there is a potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly. This issue occurs when the tab of some distractors is oversized.
The affected units were distributed worldwide, including in the United States (specifically California, Louisiana, Massachusetts, New York, and Pennsylvania), Canada, and Switzerland. All lots are included in this recall. No specific dates or lot numbers are provided in the source text.
The recalled product
- Product
- Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 596
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)
- All Lots
Distribution
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