Device product
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
Z-1048-2018
Product summary
- Event
- Event 78706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,227 in total
- Official record key
device-enforcement:Z-1048-2018
Official wording
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Code information: 00-5952-016-01 61774124 00-5952-016-01 61782595 00-5952-016-06 11004288 00-5952-017-01 11005095
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
Derived failure modes
-
Unknown
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.