Recall Z-1817-2016— Biomet, Inc.

Name: FDA recall Z-1817-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-01

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2016-04-01, terminated 2017-05-23. It names 2 FDA 510(k) clearances: K111663, K093880. Product: Various trauma and sports medicine instruments and implants. Plate, fixation, bone.. Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-01
Terminated: 2017-05-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K111663 — TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc.·cleared 2012-03-12
K093880 — PEANUT GROWTH CONTROL PLATING SYSTEMEbi, L.P.·cleared 2010-04-16

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

Various trauma and sports medicine instruments and implants. Plate, fixation, bone.

Reason for recall

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

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