Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1014-2018)

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:

BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement

Product Classification:

Class II

Date Initiated: November 29, 2017

Date Posted: March 21, 2018

Recall Number: Z-1014-2018

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:

Item Number: 00-5001-048-00 Lot Number: 62202263

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