Skip to content
Recall Observatory FDA recall evidence

Device product

LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability

Z-1038-2018

November 29, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 78706
Status
Terminated
Classification
Class II
Quantity
13,227 in total
Official record key
device-enforcement:Z-1038-2018

Official wording

Reason: 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.

Code information: 00-5992-017-91 61928631 00-5990-017-91 61771841

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.