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U.S. Department of Health and Human Services

Class 3 Device Recall ENDOBON XENOGRAFT GRANULES 0.5 ML

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  Class 3 Device Recall ENDOBON XENOGRAFT GRANULES 0.5 ML see related information
Date Initiated by Firm October 03, 2013
Date Posted March 19, 2014
Recall Status1 Terminated 3 on December 11, 2014
Recall Number Z-1233-2014
Recall Event ID 67194
510(K)Number K980679  
Product Classification Bone grafting material, synthetic - Product Code LYC
Product ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute)

Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
Code Information Model # ROX05, Batch # S0171051
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Alfredo Ferrer
561-776-6706
Manufacturer Reason
for Recall		 Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
FDA Determined
Cause 2		 Error in labeling
Action Biomet 3i sent a Medical Advisory Notice dated October 3, 2013 via mail, facsimile or telephone to all affected customers. The notice identified the product, the problem, and the action to be taken by the customers. The customers were instructed to do the following: 1) Review their inventor for any incorrectly labeled products and return them to their local Biomet distributor. 2) Provide this information to persons in their organization that uses or order these products. 3) Ensure that a copy of this letter is provided to any other organization to which the products maybe have been transferred. Customer were also instructed to respond to the attached Response Form via fax at 561-514-6316 or email to: domesticcomplaints@biomet.com. For any questions or concerns, call Biomet 3i Customer Service at 1-800-342-5454. For questions regarding this recall call 561-776-6706.
Quantity in Commerce 704
Distribution Worldwide Distribution - USA including CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA and Hawaii and Internatially to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.
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 = LYC and Original Applicant = BIOMET, INC.
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