Reported Aug 27, 2014 · Terminated
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing…
Ortho Development Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho Development Corporation · 12187 Business Park Dr · Draper, UT · 84020-8663
Is this the product you have?
- Pivot Bipolar Cup 22x42/43-51/53mm
- REF 133-YYYY Product UsageUsed in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
- Lot codes and dates
16 of 16 products
Products covered by this recall Model / number Product as published 133-2243Lot A136254,Pivot Bipolar Cup 22x43mm 133-2243Lot A136256,Pivot Bipolar Cup 22x43mm 133-2244Lot A136255,Pivot Bipolar Cup 22x44mm 133-2245Lot A136257,Pivot Bipolar Cup 22x45mm 133-2246Lot A136258,Pivot Bipolar Cup 22x46mm 133-2246Lot A136259,Pivot Bipolar Cup 22x46mm 133-2247Lot A136260,Pivot Bipolar Cup 22x47mm 133-2248Lot A136261,Pivot Bipolar Cup 22x48mm 133-2249Lot A136262,Pivot Bipolar Cup 22x49mm 133-2250Lot A136263,Pivot Bipolar Cup 22x50mm 133-2251Lot A136265,Pivot Bipolar Cup 22x51mm 133-2253Lot A136266,Pivot Bipolar Cup 22x53mm 133-2253Lot A136269,Pivot Bipolar Cup 22x53mm 133-2253Lot A136268,Pivot Bipolar Cup 22x53mm 133-2253Lot A136267,Pivot Bipolar Cup 22x53mm — Lot A136270 - Amount recalled
- 188
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- VA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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