FDA-Device2014-08-27Class II
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
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
188
Manufactured in
12187 Business Park Dr, Draper, UT, United States
Products
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2253-2014Don't want to check this manually?
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