ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from cer

FDA device recall Z-1233-2014 · posted 2014-03-19 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

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.

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

LYC

Quantity affected

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),

Date initiated

2013-10-03

Date posted

2014-03-19

Date terminated

2014-12-11

Location

Palm Beach Gardens, FL

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