Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1057-2018)

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:

NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Product Classification:

Class II

Date Initiated: November 29, 2017

Date Posted: March 21, 2018

Recall Number: Z-1057-2018

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:

00-5762-016-52 Knee LPS-FLEX GSF POR FEM, F-R

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