Recall Z-1755-2015— Biomet, Inc.

Name: FDA recall Z-1755-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-16

Class III · Terminated

Class III FDA medical device recall by Biomet, Inc., initiated 2015-04-16, terminated 2016-05-16. It names one FDA 510(k) clearance: K060692. Product: Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.. Reason: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes..

Recalling firm: Biomet, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-04-16
Terminated: 2016-05-16
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

Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.

Reason for recall

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

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