Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1858-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.

Product Classification:

Class II

Date Initiated: February 17, 2017

Date Posted: April 26, 2017

Recall Number: Z-1858-2017

Event ID: 76507

Reason for Recall:

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Status: Terminated

Product Quantity: 28,253 in total

Code Information:

Item 163005 Lot 309030

Distribution Pattern:

Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK

Voluntary or Mandated:

Voluntary: Firm initiated