Biomet, Inc. recalls ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended…

Recall date

February 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1363-2015

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.