Z-1027-2018 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
VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR 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: 00-7843-013-07 Lot Numbers: 61946025 61735805 61993658 61768679 62029060 61815080 62043103 61879441 77000599 Item Number: 00-7843-015-07 Lot Number: 62135320 Item Number: 00-7843-016-17 Lot Numbers: 61879439 61993648