Recall Z-1819-2016— Biomet, Inc.

Name: FDA recall Z-1819-2016
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 4 FDA 510(k) clearances: K091976, K063570, K050118 and 1 more. Product: Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.. 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

4 on FDA's record

K091976 — BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAILBiomet Trauma·cleared 2009-08-17
K063570 — BIOMET TIBIAL LOCKING NAIL SYSTEMBiomet Manufacturing Corp·cleared 2007-02-27
K050118 — EBI TROCHANTERIC NAIL SYSTEMEbi, L.P.·cleared 2005-02-16
K871539 — ZINDRICK IM RODBuckman Co., Inc.·cleared 1987-08-17

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. Rod, fixation, intramedullary and accessories.

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.