Z-1605-2015 Class II Terminated
FDA device recall Z-1605-2015 was initiated by BioHorizons Implant Systems Inc on Apr 16, 2015 and is designated Class II. 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. The recall status is terminated (terminated Aug 7, 2015). Affected quantity: 48 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2015
- Initiation Date
- Apr 16, 2015
- Termination Date
- Aug 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
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.
Distribution Pattern
US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.
Code Information
Lot Number 1501968
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1605-2015
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026