Z-1058-2014Class II

External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300...

Name: Z-1058-2014 External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300...
Creator: BioHorizons Implant Systems Inc
Published: 2013-12-10
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2013-12-10 / Terminated / root cause: labeling and UDI

FDA source

BioHorizons Implant Systems Inc began a recall of External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental on 2013-12-10. FDA classified it as Class II and gives the reason as "The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1058-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Posted: 2014-02-20
Terminated: 2014-03-28
Recalling firm: BioHorizons Implant Systems Inc
Product: External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: The firm, BioHorizons, sent an "Urgent Medical Device Recall" letter dated December 10, 2013 to its Consignees. The letter described the product, problem and actions to be taken. The customers were instructed to return unused affected implants and receive replacements free of charge; complete and return the enclosed Customer Reply Form via fax to (205) 484-2195 or scan to PDF and e-mail to [email protected]; If you have affected implants, upon receipt of your completed Customer Reply Form, you will be contacted by BioHorizons Customer Care and provided a Return Authorization number. In addition, if you have already placed any affected implants without incident, no special patient action needs to be taken. If you have any questions regarding this information, please contact our Customer Care Department at (888) 246-8338, Monday through Friday, 7:30am to 6:00pm Central Time.
Quantity in commerce: 119 units
Distribution: Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
Product codes and lots: Lot Number 1302762, Exp 31 MAY 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1058-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1058-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

Product code DZE

K030463Class IIModification to the Maestro SystemBioHorizons Implant Systems, Inc. / cleared 2003-02-26

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)