Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1029-2018)

VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Class II

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.

Item Number: 00-7843-012-08 Lot Numbers: 62053685 62116471 Item Number: 00-7843-013-08 Lot Number: 62184774 Item Number: 00-7843-014-08 Lot Numbers: 62184777 62158847 62184778 Item Number: 00-7843-013-81 Lot Numbers: 61987954 61815082 62116484 61956726 Item Number: 00-7843-015-08 Lot Number: 62158851 Item Number: 00-7843-013-82 Lot Numbers: 61937673 61759258 61951276 61815083 62120674 61829373 77000819 Item Number: 00-7843-015-81 Lot Numbers: 61968101 61781981 61968103 Item Number: 00-7843-015-82 Lot Numbers: 61834826 61932605 Item Number: 00-7843-016-81 Lot Numbers: 61735809 61759260 Item Number: 00-7843-016-82 Lot Numbers: 62029071 61775246 62029071N 61981820 77000820

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.

Voluntary: Firm initiated