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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, 4mmsee related information
Date Initiated by FirmSeptember 07, 2010
Date PostedNovember 04, 2010
Recall Status1 Terminated 3 on December 13, 2010
Recall NumberZ-0321-2011
Recall Event ID 56785
510(K)NumberK053152 
Product Classification Root-Form Endosseous Implant - Product Code DZE
ProductSingle-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/
Manufacturer		 BioHorizons Implant Systems Inc
2300 Riverchase Ctr
Birmingham AL 35244-2808
For Additional Information ContactWinston Greer
205-967-7880
Manufacturer Reason
for Recall		Healing abutment may not fully seat on the implant.
FDA Determined
Cause 2		Other
ActionConsignees 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 Commerce396
DistributionWorldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.
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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