FDA recall Z-0539-2018
Implant Direct Sybron Manufacturing, LLC · Class II · device
Product
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Reason for recall
InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Distribution
CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
Key facts
- Status
- Terminated
- Initiation date
- 2018-01-23
- Report date
- 2018-02-14
- Termination date
- 2018-08-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Westlake Village, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0539-2018