Tibial Tray Nonporous A recall
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Why was Tibial Tray Nonporous A recalled?
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: A200590
- Product
- Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
- Recalling firm
- Ortho Development Corporation
- Quantity
- 27
- Distribution
- US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)