Home / Recalls / Zimmer Biomet, Inc. / Z-1858-2017

Z-1858-2017 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-1858-2017 was initiated by Zimmer Biomet, Inc. on February 17, 2017 and is designated Class II. Reason for recall: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. The recall status is terminated (terminated January 29, 2018). Affected quantity: 28,253 in total.

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
February 17, 2017
Termination Date
January 29, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28,253 in total

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.

Reason for Recall

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

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

Code Information

Item 163005 Lot 309030

Other recalls by Zimmer Biomet, Inc.

  • Z-0696-2021 Class II — Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutt (November 20, 2020)
  • Z-0570-2021 Class II — Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacr (November 17, 2020)
  • Z-0385-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (September 24, 2020)
  • Z-0379-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d (September 24, 2020)
  • Z-0325-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut (September 24, 2020)
  • Z-0367-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d (September 24, 2020)
  • Z-0370-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d (September 24, 2020)
  • Z-0330-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut (September 24, 2020)
  • Z-0340-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neut (September 24, 2020)
  • Z-0386-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d (September 24, 2020)

FDA data resources