Knee Prosthesis recall
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to…
Why was Knee Prosthesis recalled?
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
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?
Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
- Product
- Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to…
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 6 units of catalog 5521-B-400
- Distribution
- Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)