Device product
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Z-1058-2014
Product summary
- Event
- Event 67090
- Status
- Terminated
- Classification
- Class II
- Quantity
- 119 units
- Official record key
device-enforcement:Z-1058-2014
Official wording
Reason: The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Code information: Lot Number 1302762, Exp 31 MAY 2018
Distribution pattern: Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
Derived failure modes
-
Unknown
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.