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U.S. Department of Health and Human Services

Class 2 Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3

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 Class 2 Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3see related information
Date Initiated by FirmDecember 10, 2013
Date PostedFebruary 20, 2014
Recall Status1 Terminated 3 on March 28, 2014
Recall NumberZ-1058-2014
Recall Event ID 67090
510(K)NumberK030463 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductExternal Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Code Information Lot Number 1302762, Exp 31 MAY 2018
Recalling Firm/
Manufacturer		 BioHorizons Implant Systems Inc
2300 Riverchase Center
Birmingham AL 35244-2808
For Additional Information ContactWinston Greer
205-986-1205
Manufacturer Reason
for Recall		The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionThe firm, BioHorizons, sent an "Urgent Medical Device Recall" letter dated December 10, 2013 to its Consignees. The letter described the product, problem and actions to be taken. The customers were instructed to return unused affected implants and receive replacements free of charge; complete and return the enclosed Customer Reply Form via fax to (205) 484-2195 or scan to PDF and e-mail to implants@biohorizons.com; If you have affected implants, upon receipt of your completed Customer Reply Form, you will be contacted by BioHorizons Customer Care and provided a Return Authorization number. In addition, if you have already placed any affected implants without incident, no special patient action needs to be taken. If you have any questions regarding this information, please contact our Customer Care Department at (888) 246-8338, Monday through Friday, 7:30am to 6:00pm Central Time.
Quantity in Commerce119 units
DistributionWorldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
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 = DZE
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