Device product
Gender Solutions" Patello-Femoral Component
Z-0077-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 65799
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5103
- Official record key
device-enforcement:Z-0077-2014
Official wording
Reason: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Code information: Part Number Range:00-5926-011/015-01/02
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
Derived failure modes
-
Unknown
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.