| Class 3 Device Recall Emergence Profile (EP) Healing Abutment | |
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
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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/ Manufacturer |
Biomet 3i, Inc. 4555 Riverside Drive Palm Beach Gardens FL 33410
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NHA
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