Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1034-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
Product Classification:
Class II
Date Initiated: November 29, 2017
Date Posted: March 21, 2018
Recall Number: Z-1034-2018
Event ID: 78706
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.
Status: Terminated
Product Quantity: 13,227 in total
Code Information:
00-5996-018-92 61836677
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.
Voluntary or Mandated:
Voluntary: Firm initiated