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Terminated

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

FDA Recall Z-1364-2015 · Posted 2015-04-02

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDR
Date Initiated2015-02-26
Date Terminated2016-01-12
Product Quantity50 Units

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.

Firm Action

Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101063SLEEVE WITH ZIPLOOP FIXATION DEVICESBiomet Sports Medicine · 2010-06-23K080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSBiomet Manufacturing, Inc. · 2008-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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