Z-0321-2011

Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44...

Name: Z-0321-2011 Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44...
Creator: BioHorizons Implant Systems Inc
Published: 2010-09-07
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2010-09-07 / Terminated

FDA source

BioHorizons Implant Systems Inc began a recall of 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... on 2010-09-07. The reason FDA records is "Healing abutment may not fully seat on the implant". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0321-2011
Status: Terminated
Initiated: 2010-09-07
Posted: 2010-11-04
Terminated: 2010-12-13
Recalling firm: BioHorizons Implant Systems Inc
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.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Healing abutment may not fully seat on the implant.
FDA root cause: Other
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.
Product codes and lots: Lot #0903233

Product code DZE

K053152Class IIBiohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. / cleared 2005-12-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)