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U.S. Department of Health and Human Services

Class 3 Device Recall Emergence Profile (EP) Healing Abutment

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  Class 3 Device Recall Emergence Profile (EP) Healing Abutment see related information
Date Initiated by Firm February 14, 2008
Date Posted March 29, 2008
Recall Status1 Terminated 3 on July 10, 2008
Recall Number Z-1366-2008
Recall Event ID 47342
510(K)Number K072642  
Product Classification Profile Healing Abutment - Product Code NHA
Product BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
Code Information Lot Number: 770147
Recalling Firm/
Biomet 3i, Inc.
4555 Riverside Drive
Palm Beach Gardens FL 33410
For Additional Information Contact
561-776-6700 Ext. 6819
Manufacturer Reason
for Recall
Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)
FDA Determined
Cause 2
Process control
Action Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.
Quantity in Commerce 254
Distribution Worldwide
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.