Recall Z-1756-2015— Biomet, Inc.

Name: FDA recall Z-1756-2015
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 2 FDA 510(k) clearances: K142933, K915132. Product: MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar 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

2 on FDA's record

K142933 — Biomet Tibial traysBiomet, Inc.·cleared 2014-12-23
K915132 — MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEMBiomet, Inc.·cleared 1992-02-11

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

MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar 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.