Inbone Stem recall: Sterility Concern
INBONE STEM, TIBIAL, TOP, Part Number 200011901
Why was Inbone Stem recalled?
The firm discovered a lack of adequate documentation confirming sterility on certain products.
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?
Lot Number 1540433
- Product
- INBONE STEM, TIBIAL, TOP, Part Number 200011901
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 65 units
- Distribution
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)