FDAFDA · Food and drugs·Recall number Z-2254-2014
Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
Published August 27, 2014 · Recall initiated: July 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ortho Development Corporation
- Distributor
- Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
- Lot
- Patella 38mm Part 164-0038, Lot A135844
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.