Tibila Insert CK recall
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a…
Why was Tibila Insert CK recalled?
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
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?
CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666
- Product
- Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a…
- Recalling firm
- Ortho Development Corporation
- Quantity
- 1
- Distribution
- Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
- Recall date
- August 27, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)