Z-0391-2016Class II

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R)...

Name: Z-0391-2016 RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R)...
Creator: BioHorizons Implant Systems Inc
Published: 2015-10-30
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2015-10-30 / Terminated / root cause: manufacturing process

FDA source

BioHorizons Implant Systems Inc began a recall of RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant on 2015-10-30. FDA classified it as Class II and gives the reason as "An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0391-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-30
Posted: 2015-12-07
Terminated: 2016-02-04
Recalling firm: BioHorizons Implant Systems Inc
Product: RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: BioHorizons sent an Urgent Medical Device Field Correcton letter dated Friday, October 30, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete the enclosed Customer Reply Form and fax to 205-484-2195 or scan to PDF and e-mail to [email protected]. The sole international consignee was notified Monday, 02 November 2015. Customers with questions were instructed to contact the Customer Care Department at 888-246-8338. For questionsn regarding this recall call 205-986-1205.
Quantity in commerce: 32 units
Distribution: Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
Product codes and lots: Lot 1404442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0391-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0391-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-07

Product code DZE

K073268Class IIBiohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. / cleared 2008-02-08

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)