Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surf
FDA device recall Z-2253-2014 · posted 2014-08-17 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 188
- Distribution
- Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
- Date initiated
- 2014-07-11
- Date posted
- 2014-08-17
- Date terminated
- 2014-10-06
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PIVOT BIPOLAR FEMORAL HEAD (K050966) | Ortho Development Corp. | 2005-07-07 |