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U.S. Department of Health and Human Services

Class 2 Device Recall Singlestage 3.5mm Healing Abutment, 4mm

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  Class 2 Device Recall Singlestage 3.5mm Healing Abutment, 4mm see related information
Date Initiated by Firm September 07, 2010
Date Posted November 04, 2010
Recall Status1 Terminated 3 on December 13, 2010
Recall Number Z-0321-2011
Recall Event ID 56785
510(K)Number K053152  
Product Classification Root-Form Endosseous Implant - Product Code DZE
Product Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244.

Endosseous dental implant healing abutment.
Code Information Lot #0903233
Recalling Firm/
BioHorizons Implant Systems Inc
2300 Riverchase Ctr
Birmingham AL 35244-2808
For Additional Information Contact Winston Greer
Manufacturer Reason
for Recall
Healing abutment may not fully seat on the implant.
FDA Determined
Cause 2
Action Consignees were notified by an Urgent: Medical Device Recall letter on 09/07/2010. The letter identified the affected product and gave some background regarding the issue. It also stated the possible impact and the cases that were not affected. Consignees were instructed to contact BioHorizons Returns & Complaints Manager Rick Self at 205-986-1250, if they have unused product from the affected lot, for a Return Authorization Number and to receive replacements. The attached Notification Certification form is to be completed and returned via fax.
Quantity in Commerce 396
Distribution Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.
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 = DZE and Original Applicant = BIOHORIZONS IMPLANT SYSTEMS, INC.