Skip to content
Recall Observatory FDA recall evidence

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

April 16, 2015

Class II

Product summary

Firm
BioHorizons Implant Systems Inc
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

    reason.no_named_rule · v1.0.0

    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.