Wright Medical Recalls Inbone Tibial Trays Missing Plasma Coating
Wright Medical Technology Inc is recalling 22 units of Inbone Tibial Trays because one lot is missing the required plasma coating.
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 illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a manufacturing defect without reported harm.
Plain-English summary
Wright Medical Technology Inc is recalling 22 units of Inbone Tibial Trays, Size 2, Plasma Spray, Left (REF 2000252902). The recall involves Lot code 1619947, which was distributed nationwide in the United States.
The recall was initiated because the specific lot of tibial trays is missing the plasma coating. This product is intended to give a patient limited mobility by reducing pain, restoring alignment, and replacing the flexion and extension movement in the ankle joint.
Consumers and healthcare providers should stop using the affected devices and contact Wright Medical Technology Inc for further instructions.
The recalled product
- Product
- WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
- Manufacturer
- Wright Medical Technology Inc
- Hazard
- Affected units
- 22
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)
- Lot code 1619947
Distribution
Distributed nationwide across the United States.
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