Recall Z-2820-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-2820-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-08

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-06-08, terminated 2020-04-14. It names one FDA 510(k) clearance: K090757. Product: ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.. Reason: Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Terminated: 2020-04-14
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K090757 — BIOMET MODULAR FEMORAL REVISION SYSTEMBiomet, Inc.·cleared 2009-09-25

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

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

Reason for recall

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

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