Z-0539-2018 Class II Terminated
FDA device recall Z-0539-2018 was initiated by Implant Direct Sybron Manufacturing, LLC on January 23, 2018 and is designated Class II. Reason for recall: InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. The recall status is terminated (terminated August 9, 2018). Affected quantity: 55 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- January 23, 2018
- Termination Date
- August 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
Product Description
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 Pattern
CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
Code Information
Lot Number 104203