Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only recallZ-1605-2015 · BioHorizons Implant Systems Inc · initiated Apr 16, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioHorizons Implant Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1605-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 16, 2015
- Posted by the FDA
- May 12, 2015
- Recalling firm
- BioHorizons Implant Systems Inc
- Quantity
- 48 units
- Product code
- DZE
- FDA submissions
- K071638
- 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 description
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
Code information (models, lots, serial numbers)
Lot Number 1501968
Other devices under the same FDA submission
121 devices cleared under K071638 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BioHorizons BTA4212Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,805 reports
- BioHorizons BTA4210Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,803 reports
- BioHorizons BTA5210Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,164 reports
- BioHorizons TLX3810Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,132 reports
- BioHorizons TRX3810Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,124 reports
- BioHorizons BTA4610Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,099 reports
- BioHorizons BTA3810Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,091 reports
- BioHorizons BTA5209Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,065 reports
- BioHorizons TLX3812Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,053 reports
- BioHorizons TLX3010Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form1,030 reports
- BioHorizons BTA4209Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form987 reports
- BioHorizons BTA3812Biohorizons Implant Systems, Inc · Implant, Endosseous, Root-Form939 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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