Device product
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
Z-1605-2015
Product summary
- Event
- Event 71125
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-1605-2015
Official wording
Reason: 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.
Code information: Lot Number 1501968
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.
Derived failure modes
-
Unknown
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.