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U.S. Department of Health and Human Services

Class 2 Device Recall Ziploop Button

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 Class 2 Device Recall Ziploop Buttonsee related information
Date Initiated by FirmFebruary 26, 2015
Date PostedApril 02, 2015
Recall Status1 Terminated 3 on January 12, 2016
Recall NumberZ-1364-2015
Recall Event ID 70667
510(K)NumberK080088 K101063 
Product Classification Staple, fixation, bone - Product Code JDR
ProductZiploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
Code Information PN: 110010873 Lot: 209340
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information ContactAudrey Daenzer
574-372-1570
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionBiomet 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.
Quantity in Commerce50 Units
DistributionWorldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JDR
510(K)s with Product Code = JDR
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