Recall Z-1859-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-1859-2017
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 3 FDA 510(k) clearances: K080642, K060694, K992119. Product: various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement. 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

3 on FDA's record

K080642 — COMPREHENSIVE REVERSE SHOULDERBiomet, Inc.·cleared 2008-07-09
K060694 — MODULAR HYBRID GLENOIDBiomet Manufacturing Corp·cleared 2006-12-11
K992119 — BIO-MODULAR SHOULDER SYSTEMBiomet, Inc.·cleared 1999-09-13

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 Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement

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.