Z-1605-2015Class II

Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in...

Name: Z-1605-2015 Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in...
Creator: BioHorizons Implant Systems Inc
Published: 2015-04-16
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2015-04-16 / Terminated / root cause: manufacturing process

FDA source

BioHorizons Implant Systems Inc began a recall of Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement on 2015-04-16. FDA classified it as Class II and gives the reason as "BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium". 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-1605-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Posted: 2015-05-12
Terminated: 2015-08-07
Recalling firm: BioHorizons Implant Systems Inc
Product: Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BioHorizons sent an Urgent Medical Device Field Correction letter on 04/16/2015 to affected customers. Non-responding customers will be notified after 30 days. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Care Department at 888-246-8338.
Quantity in commerce: 48 units
Distribution: US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.
Product codes and lots: Lot Number 1501968

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1605-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1605-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-12

Product code DZE

K071638Class IIBiohorizons Tapered Internal Implant SystemBioHorizons Implant Systems, Inc. / cleared 2007-10-10

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)