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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Inc., Biomet Sports Medicine, and Biomet

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  Class 2 Device Recall Biomet Inc., Biomet Sports Medicine, and Biomet see related information
Date Initiated by Firm April 01, 2016
Date Posted May 26, 2016
Recall Status1 Terminated 3 on May 23, 2017
Recall Number Z-1822-2016
Recall Event ID 74038
510(K)Number K831005  
Product Classification Pin, fixation, smooth - Product Code HTY
Product Various trauma and sports medicine instruments and implants.
Pin, fixation, smooth.
Code Information Part #'s 24415 24416 27914 27922 328010 14-401440 14-450360 14-450365 14-450380 14-450390 35-361681  Lot #'s 679900 693860 729090 722660 668350 591000 591010 591020 652700 745110 752860 728860 652650 664410 664440 606280  
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
FDA Determined
Cause 2		 Equipment maintenance
Action Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Distribution Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HTY and Original Applicant = KIRSCHNER MEDICAL CORP.
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