Recall Z-1363-2015— Biomet, Inc.

Name: FDA recall Z-1363-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-26

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-02-26, terminated 2016-01-12. It names 2 FDA 510(k) clearances: K141263, K130033. Product: ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.. Reason: The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Terminated: 2016-01-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

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

ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.

Reason for recall

The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.

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