INBONE Total Ankle System Recalled Due to Package Labeling Mismatch
Wright Medical Technology is recalling the INBONE Total Ankle System because package contents do not match the package labeling on affected units distributed in Michigan and Pennsylvania.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class II recall for a packaging and labeling mismatch with no reported illnesses, injuries, or adverse events. Per the rubric, documentation issues and packaging-only problems are classified as Low severity.
Plain-English summary
Wright Medical Technology Inc is recalling two units of the INBONE Total Ankle System, INBONE POLY INSERT Size 2+ with 14mm Sulcus (Model 220223214E, Lot Code 06113718691661809).
The package contents do not match the package labeling on these affected units. The units were distributed nationwide in Michigan and Pennsylvania.
Patients and healthcare facilities who received units with the recalled lot code should contact Wright Medical Technology Inc to verify the accuracy of their received product and package labeling.
The recalled product
- Product
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
- Manufacturer
- Wright Medical Technology Inc
- Hazard
- Affected units
- 2
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 220223214E
- Lot Code 06113718691661809 (GTIN: 00840420125033)
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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