Recall Z-2253-2014 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Ortho Development Corporation
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
| Date | Aug 17, 2014 (initiated Jul 11, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification. |
| Quantity | 188 |
| Distribution | Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050966 | PIVOT BIPOLAR FEMORAL HEAD Ortho Development Corp., Jul 7, 2005 |