Z-1019-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- November 29, 2017
- Termination Date
- April 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,227 in total
Product Description
CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Reason for Recall
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.
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.
Code Information
Item Number: 00-8114-002-00 Lot Numbers: 62326105 61779347 62327662 62240744 62327663 62240745 62330760 62250379 62333960 62256011 62340054 62264280 62344682 62268572 62370963 62273048 62370965 62273049 62370966 62275085 62298278 62276441 62370975 62277490 62298279 62370968 62303495 62370969 62317907 62278684 62320168 62284463 62320169 62370971 62370976 62370972 62370978 62291922 62370979 62370973 62370990 62326104