Synthes XRL Medium Trial Central Body Recalled for Incorrect Dimension Etching
Synthes, Inc. is recalling two lots of the Synthes XRL Medium Trial-Central Body device because they were incorrectly etched with the wrong height dimensions.
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, and the hazard involves incorrect labeling (etching) of dimensions without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes, Inc. is recalling two lots of the Synthes XRL Medium Trial-Central Body device. This instrument is used as part of the Synthes XRL System, a vertebral body replacement device intended for spinal surgery. The recall involves three units distributed in the United States, including the states of Florida, New Jersey, and Minnesota.
The recall was initiated because the devices were incorrectly etched with the incorrect dimensions for height. The affected products are identified by product number 03.807.507, lot number 8029684, and product number 03.807.508, lot number 8029689.
Healthcare facilities and distributors should stop using the affected devices and contact Synthes, Inc. for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including…
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 3
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)
- Product no. 03.807.507
- lot no. 8029684
- and product no. 03.807.508
- lot no. 8029689.
Distribution
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