Device product
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Z-1018-2018
Product summary
- Event
- Event 78706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,227 in total
- Official record key
device-enforcement:Z-1018-2018
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: Item Number: 00-8114-002-10 Lot Numbers: 61744467 61762055 61783714 62249024 62249025 62250377 62250378 62257221 62257223 62261916 62261917
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.