FDA-Device2014-08-27Class II
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Ortho Development Corporation
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Affected count
13
Manufactured in
12187 Business Park Dr, Draper, UT, United States
Products
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2256-2014Don't want to check this manually?
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