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U.S. Department of Health and Human Services

Class 2 Device Recall BIOMET 3i

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  Class 2 Device Recall BIOMET 3i see related information
Date Initiated by Firm June 25, 2014
Date Posted September 05, 2014
Recall Status1 Terminated 3 on September 23, 2014
Recall Number Z-2594-2014
Recall Event ID 68915
510(K)Number K072642  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product BIOMET 3i Certain Bellatek Encode Healing Abutment

Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Code Information Model Number IEHA458, Lot number: 1167545.
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Mark Mashburn
561-776-6700
Manufacturer Reason
for Recall		 Identifiers on the label are correct but the label has the incorrect color coding.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Biomet 3i sent an Urgent - Medical Device Removal letter / and by phone call on and dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. If you have any Certain BellaTek Encode Healing Abutment(s) of the affected lot in your practice, please return the abutment(s) to BIOMET 3i in exchange for Cettain BellaTek Encode Healing Abutments, IEHA458 with a proper color stripe. Alternatively, you may return the Certain BellaTek Healing Abutment(s) for full credit. We also ask that you confirm receipt of this notification by completing the attached Recall Return Response Form, indicating your preference for replacement or credit and/ or notifying us if the product was used. Thank you for your support - we are committed to maintaining high standards of quality for all our products and apologize for any inconvenience this may have caused you. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.
Quantity in Commerce 6 units
Distribution US Distribution to NH and TX.
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 = NHA and Original Applicant = BIOMET 3I, INC.
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