Recall Z-1858-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-1858-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-17

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-02-17, terminated 2018-01-29. It names one FDA 510(k) clearance: K800144. Product: 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: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-17
Terminated: 2018-01-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K800144 — FEMORAL CEMENT RESTRICTORBiomet, Inc.·cleared 1980-02-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.