FDA-Device2018-03-21Class II
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Zimmer Biomet, Inc.
Hazard
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.
Sold states
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.
Affected count
13,227 in total
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2018Don't want to check this manually?
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