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Ortho Development Corporation recalls PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing s
Recalled August 27, 2014 · FDA recall Z-2255-2014 · Ortho Development
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. · FDA Class II
Units
11
Sold at
Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Description
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.
Product
PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Manufacturer(s)
Ortho Development Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →