INBONE Total Ankle System recall: Labeling Error
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Why was INBONE Total Ankle System recalled?
The package contents and package labeling do not match.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)
- Product
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
- Recalling firm
- Wright Medical Technology Inc
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of MI and PA.
- Recall date
- December 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)