Device product
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Z-0391-2016
Product summary
- Event
- Event 72598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-0391-2016
Official wording
Reason: An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Code information: Lot 1404442
Distribution pattern: Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
Derived failure modes
-
Labeling or packaging
incorrect label