Recall Z-0980-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0980-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-08

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-12-08, terminated 2018-09-04. It names one FDA 510(k) clearance: K060692. Product: Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty. Reason: Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Terminated: 2018-09-04
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060692 — COMPREHENSIVE PRIMARY SHOULDER STEMSBiomet Manufacturing Corp·cleared 2006-05-30

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

Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

Reason for recall

Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

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