Recall Z-1757-2015— Biomet, Inc.

Name: FDA recall Z-1757-2015
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: K911684. Product: Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.. 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

K911684 — BIOMET COBALT-CHROME FEMORAL COMPONENTSBiomet, Inc.·cleared 1991-06-27

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

Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.

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.