Synthes Trial Spacers Recalled for Modified Manufacturing Process
Synthes (USA) Products LLC is recalling nine trial spacers with T-handles because they were modified outside of the approved manufacturing process.
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 hospitalizations, injuries, or illnesses, and the hazard is a procedural deviation rather than a direct physical defect causing harm.
Plain-English summary
Synthes (USA) Products LLC is recalling nine units of modified trial spacers with T-handles. The affected instruments include trial spacers in sizes 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 15mm, and 17mm. The recall was initiated because the instruments were modified outside of the approved manufacturing process.
The distribution pattern is listed as AR, and the specific lot or code information is unknown. The source text does not provide specific dates, geographic locations, or reports of patient injuries or illnesses associated with these modified instruments.
Healthcare providers and consumers who possess these specific trial spacers should stop using them and contact Synthes (USA) Products LLC for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 9
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)
- Unknown
Distribution
Distributed in 1 state:
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