Synthes 11-Hole Tubular Plate Recalled Due to Error in Release
Synthes USA HQ, Inc. is recalling 10 units of 11-Hole, 1/3 Tubular Plate DCL Plates with Collar because they were released to the US market in error.
What this means for you
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 explicitly states it is not initiated due to adverse events and is a precautionary action regarding an error in release, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling 10 units of the Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011. The specific lot number is S2004. These medical devices were distributed nationwide.
The recall was initiated because the product was released to the United States market in error. The source text explicitly states that this action is not being initiated as a result of adverse events.
Healthcare providers and facilities that have received these devices should stop using them and contact Synthes USA HQ, Inc. for instructions on how to return the product. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 10
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 (2)
- Part Number 241.000.011
- lot number S2004
Distribution
Distributed nationwide across the United States.
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