Recall Z-1103-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-1103-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-20

Class I · Terminated

Class I FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-12-20, terminated 2017-08-29. It names one FDA 510(k) clearance: K080642. Product: Comprehensive Reverse Shoulder System Humeral Tray Model 115340. Reason: Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class I
Status: Terminated
Initiated: 2016-12-20
Terminated: 2017-08-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K080642 — COMPREHENSIVE REVERSE SHOULDERBiomet, Inc.·cleared 2008-07-09

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

Comprehensive Reverse Shoulder System Humeral Tray Model 115340

Reason for recall

Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

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