INBONE Total Ankle System recalled for package-labeling mismatch
Wright Medical Technology is recalling INBONE Total Ankle System implants because the package contents and package labeling do not match.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical implant with a mismatch between package contents and labeling. Although no illnesses or injuries have been reported, the condition presents a risk of harm through potential incorrect implant selection, meeting the Score 3 criteria of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Wright Medical Technology Inc is recalling INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS implants due to a mismatch between the package contents and package labeling.
The package contents and package labeling do not match, which creates a potential for confusion or incorrect implant selection during surgical procedures.
The affected product is Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968). Two units have been quarantined. The product received US Nationwide distribution in Michigan and Pennsylvania.
Healthcare facilities and providers that have received this product should contact Wright Medical Technology Inc for further information and instructions regarding the package mismatch.
The recalled product
- Product
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
- Manufacturer
- Wright Medical Technology Inc
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)
- Model 220222210E
- Lot Code 05113580751661825 (GTIN: 00840420124968)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Wright Medical Technology Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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