FDA-Device2015-04-08Class II
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
Biomet, Inc.
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
Affected count
50 Units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1364-2015Don't want to check this manually?
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