Z-0010-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- August 7, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158 devices
Product Description
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason for Recall
The incorrect device was packaged in the vial.
Distribution Pattern
Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
Code Information
Lot 108191, UDI (01)10841307108313(17)230118(10)108191